Medical Devices
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List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing (Attachment 1)
Note: This list includes all devices that FDA historically believed either were being reprocessed or were being considered for reprocessing. It is not a current list of devices known to be reprocessed in the United States today. For a listing of devices currently being reprocessed, see FDA's web-page to search for "Cleared Reprocessed Single-Use Devices," or search FDA's device "Listing" database.
(From September 29, 2005, Federal Register Notice)
| Medical Specialty | Device Type | Regulation Number | Class | Product Code | Risk\A\ | Critical/ Semicritical/ Noncritical | Premarket Exempt | |
|---|---|---|---|---|---|---|---|---|
| 1 | Cardio | Cardiopulmonary Bypass Marker | Unclassified | MAB | 1 | C | N | |
| 2 | Cardio | Percutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA) | Post- Amendment | 3 | LOX | 3 | C | N |
| 3 | Cardio | Percutaneous Ablation Electrode | Post-Amendment | 3 | LPB | 3 | C | N |
| 4 | Cardio | Peripheral Transluminal Angioplasty (PTA) Catheter | 870.1250 | 2 | LIT | 3 | C | N |
| 5 | Cardio | Blood-Pressure Cuff | 870.1120 | 2 | DXQ | 1 | N | N |
| 6 | Cardio | Angiography Catheter | 870.1200 | 2 | DQO | 3 | C | N |
| 7 | Cardio | Electrode Recording Catheter | 870.1220 | 2 | DRF | 3 | C | N |
| 8 | Cardio | High Density Array Catheter | 870.1220 | 2 | MTD | 3 | C | N |
| 9 | Cardio | Fibeoptic Oximeter Catheter | 870.1230 | 2 | DQE | 3 | C | N |
| 10 | Cardio | Steerable Catheter | 870.1280 | 2 | DRA | 3 | C | N |
| 11 | Cardio | Steerable Catheter Control System | 870.1290 | 2 | DXX | 3 | C | N |
| 12 | Cardio | Guide Wire | 870.1330 | 2 | DQX | 3 | C | N |
| 13 | Cardio | Angiographic Needle | 870.1390 | 2 | DRC | 3 | C | N |
| 14 | Cardio | Trocar | 870.1390 | 2 | DRC | 3 | C | N |
| 15 | Cardio | Syringes | 870.1650 | 2 | DXT | 3 | C | N |
| 16 | Cardio | Injector Type Syringe Actuator | 870.1670 | 2 | DQF | 3 | C | N |
| 17 | Cardio | Oximeter | 870.2700 | 2 | DQA | 3 | N | N |
| 18 | Cardio | Tissue Saturation Oximeter | 870.2700 | 2 | MUD | 3 | C | N |
| 19 | Cardio | Intra-Aortic Balloon System | 870.3535 | 3 | DSP | 3 | C | N |
| 20 | Cardio | Vascular Clamp | 870.4450 | 2 | DXC | 3 | C | N |
| 21 | Cardio | Heart Stabilizer | 870.4500 | 1 | MWS | 2 | C | Y |
| 22 | Cardio | Noncompression Heart Stabilizer | 870.4500 | 1 | MWS | 3 | C | Y |
| 23 | Cardio | External Vein Stripper | 870.4885 | 2 | DWQ | 3 | C | N |
| 24 | Cardio | Compressible Limb Sleeve | 870.5800 | 2 | JOW | 1 | N | N |
| 25 | Dental | Bur | 872.3240 | 1 | EJL | 1 | C | Y |
| 26 | Dental | Diamond Coated Bur | 872.3240 | 1 | EJL | 3 | C | Y |
| 27 | Dental | Diamond Instrument | 872.4535 | 1 | DZP | 3 | C | Y |
| 28 | Dental | AC-Powered Bone Saw | 872.4120 | 2 | DZH | 2 | C | N |
| 29 | Dental | Manual Bone Drill and Wire Driver | 872.4120 | 2 | DZJ | 2 | C | N |
| 30 | Dental | Powered Bone Drill | 872.4120 | 2 | DZI | 2 | C | N |
| 31 | Dental | Intraoral Drill | 872.4130 | 1 | DZA | 1 | C | Y |
| 32 | Dental | Injection Needle | 872.4730 | 1 | DZM | 3 | C | Y |
| 33 | Dental | Metal Orthodontic Bracket | 872.5410 | 1 | EJF | 3 | S | Y |
| 34 | Dental | Plastic Orthodontic Bracket | 872.5470 | 2 | DYW | 3 | S | N |
| 35 | ENT | Bur | 874.4140 | 1 | EQJ | 1 | C | Y |
| 36 | ENT | Diamond Coated Bur | 874.4140 | 1 | EQJ | 3 | C | Y |
| 37 | ENT | Microdebrider | 874.4140 | 1 | EQJ | 3 | C | Y |
| 38 | ENT | Microsurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 874.4490 | 2 | LMS | 1 | S | N |
| 39 | ENT | Microsurgical Argon Fiber Optic Laser Cable, For Use In Otology | 874.4490 | 2 | LXR | 1 | S | N |
| 40 | ENT | Microsurgical Carbon-Dioxide Fiber Optic Laser Cable | 874.4500 | 2 | EWG | 1 | S | N |
| 41 | ENT | Bronchoscope Biopsy Forceps (Nonrigid) | 874.4680 | 2 | BWH | 3 | C | N |
| 42 | ENT | Bronchoscope Biopsy Forceps (Rigid) | 874.4680 | 2 | JEK | 1 | C | N |
| 43 | Gastro/Urology | Biopsy Forceps Cover | 876.1075 | 1 | FFF | 1 | C | Y |
| 44 | Gastro/Urology | Biopsy Instrument | 876.1075 | 2 | KNW | 3 | C | N |
| 45 | Gastro/Urology | Biopsy Needle Set | 876.1075 | 2 | FCG | 3 | C | N |
| 46 | Gastro/Urology | Biopsy Punch | 876.1075 | 2 | FCI | 2 | C | N |
| 47 | Gastro/Urology | Mechanical Biopsy Instrument | 876.1075 | 2 | FCF | 2 | C | N |
| 48 | Gastro/Urology | Nonelectric Biopsy Forceps | 876.1075 | 1 | FCL | 3 | C | Y |
| 49 | Gastro/Urology | Cytology Brush For Endoscope | 876.1500 | 2 | FDX | 2 | S | N |
| 50 | Gastro/Urology | Endoscope Accessories | 876.1500 | 2 | KOG | 2 | S | N |
| 51 | Gastro/Urology | Extraction Balloons/Baskets | 876.1500 | 2 | KOG | 2 | S | N |
| 52 | Gastro/Urology | Endoscopic Needle | 876.1500 | 2 | FBK | 3 | C | N |
| 53 | Gasro/Urology | Simple Pneumoperitoneum Needle | 876.1500 | 2 | FHP | 3 | C | N |
| 54 | Gastro/Urology | Spring Loaded Pneumoperitoneum Needle | 876.1500 | 2 | FHO | 3 | C | N |
| 55 | Gastro/Urology | Active Electrosurgical Electrode | 876.4300 | 2 | FAS | 3 | S | N |
| 56 | Gastro/Urology | Biliary Sphincterotomes | 876.5010, 876.1500 | 2 | FGE | 3 | C | N |
| 57 | Gastro/Urology | Electric Biopsy Forceps | 876.4300 | 2 | KGE | 3 | C | N |
| 58 | Gastro/Urology | Electrosurgical Endoscopic Unit (with or without accessories) | 876.4300 | 2 | KNS | 3 | S | N |
| 59 | Gastro/Urology | Flexible Snare | 876.4300 | 2 | FDI | 3 | S | N |
| 60 | Gastro/Urology | Flexible Suction Coagulator Electrode | 876.4300 | 2 | FEH | 3 | S | N |
| 61 | Gastro/Urology | Flexible Stone Dislodger | 876.4680 | 2 | FGO | 3 | S | Y |
| 62 | Gastro/Urology | Metal Stone Dislodger | 876.4680 | 2 | FFL | 3 | S | Y |
| 63 | Gastro/Urology | Needle Holder | 876.4730 | 1 | FHQ | 1 | C | Y |
| 64 | Gastro/Urology | Nonelectrical Snare | 876.4730 | 1 | FGX | 1 | S | Y |
| 65 | Gastro/Urology | Urological Catheter | 876.5130 | 2 | KOD | 2 | S | N |
| 66 | Gastro/Urology | Single Needle Dialysiss Set | 876.5540 | 2 | LBW, FIE | 3 | C | N |
| 67 | Gastro/Urology | Hemodialysis Blood Circuit Accessories | 876.5820 | 2 | KOC | 2 | S | N |
| 68 | Gastro/Urology | Single Needle Dialysis Set | 876.5820 | 2 | FIF | 3 | C | N |
| 69 | Gastro/Urology | Hemorrhoidal Ligator | 876.4400 | 2 | FHN | 2 | C | N |
| 70 | General Hospital | Implanted Programmable Infusion Pump | Post Amendment | 3 | LKK | 3 | C | N |
| 71 | General Hospital | Needle Destruction Device | Post Amendment | 3 | MTV | 1 | N | N |
| 72 | General Hospital | Nonpowered Flotation Therapy Mattress | 880.5150 | 1 | IKY | 2 | N | Y |
| 73 | General Hospital | NonAC-Powered Patient Lift | 880.5510 | 1 | FSA | 2 | N | Y |
| 74 | General Hospital | Alternating Pressure Air Flotation Mattress | 880.5550 | 2 | FNM | 1 | N | Y |
| 75 | General Hospital | Temperature Regulated Water Mattress | 880.5560 | 1 | FOH | 2 | N | Y |
| 76 | General Hospital | Hypodermic Single Lumen Needle | 880.5570 | 2 | FMI | 3 | C | N |
| 77 | General Hospital | Piston Syringe | 880.5860 | 2 | FMF | 3 | C | N |
| 78 | General Hospital | Mattress Cover (Medical Purposes) | 880.6190 | 1 | FMW | 2 | N | Y |
| 79 | General Hospital | Disposable Medical Scissors | 880.6820 | 1 | JOK | 1 | N | Y |
| 80 | General Hospital | Irrigating Syringe | 880.6960 | 1 | KYZ, KYY | 1 | C | Y |
| 81 | Infection Control | Surgical Gowns | 878.4040 | 2 | FYA | 1 | C | N |
| 82 | Lab | Blood Lancet | 878.4800 | 1 | FMK | 1 | C | Y |
| 83 | Neurology | Clip Forming/Cutting Instrument | 882.4190 | 1 | HBS | 3* | C | Y |
| 84 | Neurology | Drills, Burrs, Trephines & Accessories (Manual) | 882.4300 | 2 | HBG | 3* | C | N |
| 85 | Neurology | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 882.4305 | 2 | HBF | 3* | C | N |
| 86 | Neurology | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 882.4310 | 2 | HBE | 3* | C | N |
| 87 | OB/GYN | Oocyte Aspiration Needle | 3 | MHK | 3 | C | N | |
| 88 | OB/GYN | Laparoscope Accessories | 884.1720 | 1 | HET | 2 | C | Y |
| 89 | OB/GYN | Laparoscope Accessories | 884.1720 | 2 | HET | 3 | C | N |
| 90 | OB/GYN | Laparoscopic Dissectors | 884.1720 | 1 | HET | 2 | C | Y |
| 91 | OB/GYN | Laparoscopic Graspers | 884.1720 | 1 | HET | 2 | C | Y |
| 92 | OB/GYN | Laparoscopic Scissors | 884.1720 | 1 | HET | 2 | C | Y |
| 93 | OB/GYN | Insufflator Accessories (Tubing, Verres Needle, Kits) | 884.1730 | 2 | HIF | 3 | C | Y |
| 94 | OB/GYN | Laparoscopic Insufflator | 884.1730 | 2 | HIF | 2 | N | N |
| 95 | OB/GYN | Endoscopic Electrocautery and Accessories | 884.4100 | 2 | HIM | 2 | N | N |
| 96 | OB/GYN | Gynecologic Electrocautery (and Accessories) | 884.4120 | 2 | HGI | 2 | N | N |
| 97 | OB/GYN | Endoscopic Bipolar Coagulator-Cutter (and Accessories) | 884.4150 | 2 | HIN | 2 | N | N |
| 98 | OB/GYN | Culdoscopic Coagulator (and Accessories) | 884.4160 | 2 | HFI | 2 | N | N |
| 99 | OB/GYN | Endoscopic Unipolar Coagulator-Cutter (and Accessories) | 884.4160 | 2 | KNF | 2 | N | N |
| 100 | OB/GYN | Hysteroscopic Coagulator (and Accessories) | 884.4160 | 2 | HFH | 2 | N | N |
| 101 | OB/GYN | Unipolar Laparoscopic Coagulator (and Accessories) | 884.4160 | 2 | HFG | 2 | N | N |
| 102 | OB/GYN | Episiotomy Scissors | 884.4520 | 1 | HDK | 1 | C | Y |
| 103 | OB/GYN | Umbilical Scissors | 884.4520 | 1 | HDJ | 1 | C | Y |
| 104 | OB/GYN | Biopsy Forceps | 884.4530 | 1 | HFB | 3 | C | Y |
| 105 | OB/GYN | Assisted Reproduction Needle | 884.6100 | 2 | MQE | 3 | C | N |
| 106 | Ophthalmic | Endoilluminator | 876.1500 | 2 | MPA | 3* | C | N |
| 107 | Ophthalmic | Surgical Drapes | 878.4370 | 2 | KKX | 2 | C | N |
| 108 | Ophthalmic | Ophthalmic Knife | 886.4350 | 1 | HNN | 3 | C | Y |
| 109 | Ophthalmic | Keratome Blade | 886.4370 | 1 | HMY, HNO | 3 | C | N |
| 110 | Ophthalmic | Phacoemulsification Needle | 886.4670 | 2 | HQC | 3 | C | N |
| 111 | Ophthalmic | Phacoemulsification/ Phacofragmentation Fluidic | 886.4670 | 2 | MUS | 2 | C | N |
| 112 | Ophthalmic | Phacofragmentation Unit | 886.4670 | 2 | HQC | 1 | N | N |
| 113 | Orthopedic | Saw Blades | 878.4820 | 1 | GFA, DWH, GEY, GET | 1 | C | Y |
| 114 | Orthopedic | Surgical Drills | 878.4820 | 1 | GEY, GET | 1 | C | Y |
| 115 | Orthopedic | Arthroscope Accessories | 888.1100 | 2 | HRX | 2 | C | Y |
| 116 | Orthopedic | Bone Tap | 888.4540 | 1 | HWX | 1 | C | Y |
| 117 | Orthopedic | Burr | 888.4540 | 1 | HTT | 1 | C | Y |
| 118 | Orthopedic | Carpal Tunnel Blade | 888.4540 | 1 | LXH | 2 | C | Y |
| 119 | Orthopedic | Countersink | 888.4540 | 1 | HWW | 1 | C | Y |
| 120 | Orthopedic | Drill Bit | 888.4540 | 1 | HTW | 1 | C | Y |
| 121 | Orthopedic | Knife | 888.4540 | 1 | HTS | 1 | C | Y |
| 122 | Orthopedic | Manual Surgical Instrument | 888.4540 | 1 | LXH | 1 | C | Y |
| 123 | Orthopedic | Needle Holder | 888.4540 | 1 | HXK | 1 | C | Y |
| 124 | Orthopedic | Reamer | 888.4540 | 1 | HTO | 1 | C | Y |
| 125 | Orthopedic | Rongeur | 888.4540 | 1 | HTX | 1 | C | Y |
| 126 | Orthopedic | Scissors | 888.4540 | 1 | HRR | 1 | C | Y |
| 127 | Orthopedic | Staple Driver | 888.4540 | 1 | HXJ | 1 | C | Y |
| 128 | Orthopedic | Trephine | 888.4540 | 1 | HWK | 1 | C | Y |
| 129 | Orthopedic | Flexible Reamers/Drills | 886.4070/ 878.4820 | 1 | GEY, HRG | 1 | C | Y |
| 130 | Orthopedic | External Fixation Frame | 888.3040/ 888.3030 | 2 | JEC, KTW, KTT | 2 | N | N |
| 131 | Physical Medicine | Nonheating Lamp for Adjunctive Use Inpatient Therapy | 890.5500 | 2 | NHN | 1 | N | N |
| 132 | Physical Medicine | Electrode Cable | 890.1175 | 2 | IKD | 1 | N | Y |
| 133 | Physical Medicine | External Limb Component, Hip Joint | 890.3420 | 1 | ISL | 2 | N | Y |
| 134 | Physical Medicine | External Limb Component, Knee Joint | 890.3420 | 1 | ISY | 2 | N | Y |
| 135 | Physical Medicine | External Limb Component, Mechanical Wrist | 890.3420 | 1 | ISZ | 2 | N | Y |
| 136 | Physical Medicine | External Limb Component, Shoulder Joint | 890.3420 | 1 | IQQ | 2 | N | Y |
| 137 | Plastic Surgery | Stapler | 878.4800 | 1 | GAG, GEF, FHM, HBT | 2 | C | Y |
| 138 | Radiology | Isotope Needle | 892.5730 | 2 | IWF | 3 | C | N |
| 139 | Respiratory | Endotracheal Tube Changer | Unclassified | 3 | LNZ | 3 | C | N |
| 140 | Respiratory | Anesthesia Conduction Needle | 868.5150 | 2 | BSP | 3 | C | N |
| 141 | Respiratory | Short Term Spinal Needle | 868.5150 | 2 | MIA | 3 | C | N |
| 142 | Respiratory | Respiratory Therapy and Anesthesia Breathing Circuits | 868.5240 | 1 | CAI | 2 | S | Y |
| 143 | Respiratory | Oral and Nasal Catheters | 868.5350 | 1 | BZB | 1 | C | Y |
| 144 | Respiratory | Gas Masks | 868.5550 | 1 | BSJ | 1 | S | Y |
| 145 | Respiratory | Breathing Mouthpiece | 868.5620 | 1 | BYP | 1 | N | Y |
| 146 | Respiratory | Tracheal Tube | 868.5730 | 2 | BTR | 3 | C | N |
| 147 | Respiratory | Airway Connector | 868.5810 | 1 | BZA | 2 | S | Y |
| 148 | Respiratory | CPAP Mask | 868.5905 | 2 | BZD | 3 | S | N |
| 149 | Respiratory | Emergency Manual Resuscitator | 868.5915 | 2 | BTM | 2 | S | N |
| 150 | Respiratory | Tracheobronchial Suction Catheter | 868.6810 | 1 | BSY | 3 | S | Y |
| 151 | Surgery | AC-Powered Orthopedic Instrument and Accessories | 878.4820 | 1 | HWE | 2 | C | N |
| 152 | Surgery | Breast Implant Mammary Sizer | Unclassified | MRD | 1 | C | N | |
| 153 | Surgery | Ultrasonic Surgical Instrument | Unclassified | LFL | 3 | C | N | |
| 154 | Surgery | Trocar | 874.4420 | 1 | KAB, KBG, KCI | 3 | C | Y |
| 155 | Surgery | Endoscopic Blades | 876.1500 | 2 | GCP, GCR | 2 | C | N |
| 156 | Surgery | Endoscopic Guidewires | 876.1500 | 2 | GCP, GCR | 1 | C | N |
| 157 | Surgery | Inflatable External Extremity Splint | 878.3900 | 1 | FZF | 1 | N | Y |
| 158 | Surgery | Noninflatable External Extremity Splint | 878.3910 | 1 | FYH | 1 | N | Y |
| 159 | Surgery | Catheter Needle | 878.4200 | 1 | GCB | 3 | C | Y |
| 160 | Surgery | Implantable Clip | 878.4300 | 2 | FZP | 3 | C | N |
| 161 | Surgery | Electrosurgical and Coagulation Unit with Accessories | 878.4400 | 2 | BWA | 2 | C | N |
| 162 | Surgery | Electrosurgical Apparatus | 878.4400 | 2 | HAM | 2 | C | N |
| 163 | Surgery | Electrosurgical Cutting & Coagulation Device & Accessories | 878.4400 | 2 | GEI, NUJ | 2 3 | C | N |
| 164 | Surgery | Electrosurgical Device | 878.4400 | 2 | DWG | 2 | C | N |
| 165 | Surgery | Electrosurgical Electrode | 878.4400 | 2 | JOS | 2 | C | N |
| 166 | Surgery | Implantable Staple, Clamp, Clip for Suturing Apparatus | 878.4750 | 2 | GDW | 3 | C | N |
| 167 | Surgery | Percutaneous Biopsy Device | 878.4800 | 1 | MJG | 3 | C | Y |
| 168 | Surgery | Gastro-Urology Needle | 878.4800 | 1 | FHR | 3 | C | Y |
| 169 | Surgery | Aspiration and Injection Needle | 878.4800 | 1 | GAA | 3 | C | Y |
| 170 | Surgery | Biopsy Brush | 878.4800 | 1 | GEE | 1 | C | Y |
| 171 | Surgery | Blood Lancet | 878.4800 | 1 | FMK | 1 | C | Y |
| 172 | Surgery | Bone Hook | 878.4800 | 1 | KIK | 1 | C | Y |
| 173 | Surgery | Cardiovascular Biopsy Needle | 878.4800 | 1 | DWO | 3 | C | Y |
| 174 | Surgery | Clamp | 878.4800 | 1 | GDJ | 1 | C | Y |
| 175 | Surgery | Clamp | 878.4800 | 1 | HXD | 1 | C | Y |
| 176 | Surgery | Curette | 878.4800 | 1 | HTF | 1 | C | Y |
| 177 | Surgery | Disposable Surgical Instrument | 878.4800 | 1 | KDC | 1 | C | Y |
| 178 | Surgery | Disposable Vein Stripper | 878.4800 | 1 | GAJ | 1 | C | Y |
| 179 | Surgery | Dissector | 878.4800 | 1 | GDI | 1 | C | Y |
| 180 | Surgery | Forceps | 878.4800 | 1 | GEN | 2 | C | Y |
| 181 | Surgery | Forceps | 878.4800 | 1 | HTD | 2 | C | Y |
| 182 | Surgery | Gouge | 878.4800 | 1 | GDH | 1 | C | Y |
| 183 | Surgery | Hemostatic Clip Applier | 878.4800 | 1 | HBT | 2 | C | Y |
| 184 | Surgery | Hook | 878.4800 | 1 | GDG | 1 | C | Y |
| 185 | Surgery | Manual Instrument | 878.4800 | 1 | MDM, MDW | 1 | C | Y |
| 186 | Surgery | Manual Retractor | 878.4800 | 1 | GZW | 1 | C | Y |
| 187 | Surgery | Manual Saw and Accessories | 878.4800 | 1 | GDR, HAC | 1 | C | Y |
| 188 | Surgery | Manual Saw and Accessories | 878.4800 | 1 | HAC | 1 | C | Y |
| 189 | Surgery | Manual Surgical Chisel | 878.4800 | 1 | FZO | 1 | C | Y |
| 190 | Surgery | Mastoid Chisel | 878.4800 | 1 | JYD | 1 | C | Y |
| 191 | Surgery | Orthopedic Cutting Instrument | 878.4800 | 1 | HTZ | 1 | C | Y |
| 192 | Surgery | Orthopedic Spatula | 878.4800 | 1 | HXR | 1 | C | Y |
| 193 | Surgery | Osteotome | 878.4800 | 1 | HWM | 1 | C | Y |
| 194 | Surgery | Rasp | 878.4800 | 1 | GAC | 1 | C | Y |
| 195 | Surgery | Rasp | 878.4800 | 1 | HTR | 1 | C | Y |
| 196 | Surgery | Retractor | 878.4800 | 1 | GAD | 1 | C | Y |
| 197 | Surgery | Retractor | 878.4800 | 1 | HXM | 1 | C | Y |
| 198 | Surgery | Saw | 878.4800 | 1 | HSO | 1 | C | Y |
| 199 | Surgery | Scalpel Blade | 878.4800 | 1 | GES | 1 | C | Y |
| 200 | Surgery | Scalpel Handle | 878.4800 | 1 | GDZ | 1 | C | Y |
| 201 | Surgery | Scissors | 878.4800 | 1 | LRW | 1 | C | Y |
| 202 | Surgery | Snare | 878.4800 | 1 | GAE | 1 | C | Y |
| 203 | Surgery | Spatula | 878.4800 | 1 | GAF | 1 | C | Y |
| 204 | Surgery | Staple Applier | 878.4800 | 1 | GEF | 2 | C | Y |
| 205 | Surgery | Stapler | 878.4800 | 1 | GAG | 2 | C | Y |
| 206 | Surgery | Stomach and Intestinal Suturing Apparatus | 878.4800 | 1 | FHM | 2 | C | Y |
| 207 | Surgery | Surgical Curette | 878.4800 | 1 | FZS | 1 | C | Y |
| 208 | Surgery | Surgical Cutter | 878.4800 | 1 | FZT | 1 | C | Y |
| 209 | Surgery | Surgical Knife | 878.4800 | 1 | EMF | 1 | S | Y |
| 210 | Surgery | Laser Powered Instrument | 878.4810 | 2 | GEX | 2 | C | N |
| 211 | Surgery | AC-Powered Motor | 878.4820 | 1 | GEY | 2 | C | Y |
| 212 | Surgery | Bit | 878.4820 | 1 | GFG | 1 | C | Y |
| 213 | Surgery | Bur | 878.4820 | 1 | GFF, GEY | 1 | C | Y |
| 214 | Surgery | Cardiovascular Surgical Saw Blade | 878.4820 | 1 | DWH | 1 | C | Y |
| 215 | Surgery | Chisel (Osteotome) | 878.4820 | 1 | KDG | 1 | C | Y |
| 216 | Surgery | Dermatome | 878.4820 | 1 | GFD | 1 | C | Y |
| 217 | Surgery | Electrically Powered Saw | 878.4820 | 1 | DWI | 2 | C | Y |
| 218 | Surgery | Pneumatic Powered Motor | 878.4820 | 1 | GET | 2 | C | Y |
| 219 | Surgery | Pneumatically Powered Saw | 878.4820 | 1 | KFK | 2 | C | Y |
| 220 | Surgery | Powered Saw & Accessories | 878.4820 | 1 | HAB | 2 | C | Y |
| 221 | Surgery | Saw Blade | 878.4820 | 1 | GFA | 1 | C | Y |
| 222 | Surgery | Nonpneumatic Tourniquet | 878.5900 | 1 | GAX | 1 | N | Y |
| 223 | Surgery | Pneumatic Tourniquet | 878.5910 | 1 | KCY | 1 | N | Y |
| 224 | Surgery | Endoscopic Staplers | 888.4540 | 1 | HXJ | 2 | C | Y |
| 225 | Surgery | Trocar | 876.1500/ 870.1390 | 2 | GCJ, DRC | 3 | C | N |
| 226 | Surgery | Surgical Cutting Accessories | 878.4800/ 874.4420 | 1 | GDZ, GDX, GES, KBQ, KAS | 2 | C | Y |
| 227 | Surgery | Electrosurgical Electrodes/Handles/ Pencils | 876.4300/ 878.4400 | 2 | HAM, GEI, GAS | 2 | C | N |
| 228 | Surgery | Scissor Tips | 878.4800/ 884.4520/ 874.4420 | 1 | LRW, HDK, HDJ, JZB, KBD | 2 | C | Y |
| 229 | Surgery | Laser Fiber Delivery Systems | 878.4810/ 874.4500/ 886.4390/ 884.4550 | 2 | GEX, EWG, LLW, HQF, HHR, HQB | 1 | C | N |
\A\Risk categorization may be either:
1 = low risk according to RPS
2 = moderate risk according to RPS
3 = high risk according to RPS
3* = high risk due to neurological use
See section II of this document, ``FDA's Implementation of New Section 510(o) of the Act'' for methodology and criteria used to identify the risk.
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