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U.S. Department of Health and Human Services

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.