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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 SpecialtyDevice TypeRegulation NumberClassProduct CodeRisk\A\Critical/ Semicritical/ NoncriticalPremarket Exempt
1CardioCardiopulmonary Bypass MarkerUnclassified MAB1CN
2CardioPercutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA)Post- Amendment3LOX3CN
3CardioPercutaneous Ablation ElectrodePost-Amendment3LPB3CN
4CardioPeripheral Transluminal Angioplasty (PTA) Catheter870.12502LIT3CN
5CardioBlood-Pressure Cuff870.11202DXQ1NN
6CardioAngiography Catheter870.12002DQO3CN
7CardioElectrode Recording Catheter870.12202DRF3CN
8CardioHigh Density Array Catheter870.12202MTD3CN
9CardioFibeoptic Oximeter Catheter870.12302DQE3CN
10CardioSteerable Catheter870.12802DRA3CN
11CardioSteerable Catheter Control System870.12902DXX3CN
12CardioGuide Wire870.13302DQX3CN
13CardioAngiographic Needle870.13902DRC3CN
14CardioTrocar870.13902DRC3CN
15CardioSyringes870.16502DXT3CN
16CardioInjector Type Syringe Actuator870.16702DQF3CN
17CardioOximeter870.27002DQA3NN
18CardioTissue Saturation Oximeter870.27002MUD3CN
19CardioIntra-Aortic Balloon System870.35353DSP3CN
20CardioVascular Clamp870.44502DXC3CN
21CardioHeart Stabilizer870.45001MWS2CY
22CardioNoncompression Heart Stabilizer870.45001MWS3CY
23CardioExternal Vein Stripper870.48852DWQ3CN
24CardioCompressible Limb Sleeve870.58002JOW1NN
25DentalBur872.32401EJL1CY
26DentalDiamond Coated Bur872.32401EJL3CY
27DentalDiamond Instrument872.45351DZP3CY
28DentalAC-Powered Bone Saw872.41202DZH2CN
29DentalManual Bone Drill and Wire Driver872.41202DZJ2CN
30DentalPowered Bone Drill872.41202DZI2CN
31DentalIntraoral Drill872.41301DZA1CY
32DentalInjection Needle872.47301DZM3CY
33DentalMetal Orthodontic Bracket872.54101EJF3SY
34DentalPlastic Orthodontic Bracket872.54702DYW3SN
35ENTBur874.41401EQJ1CY
36ENTDiamond Coated Bur874.41401EQJ3CY
37ENTMicrodebrider874.41401EQJ3CY
38ENTMicrosurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology874.44902LMS1SN
39ENTMicrosurgical Argon Fiber Optic Laser Cable, For Use In Otology874.44902LXR1SN
40ENTMicrosurgical Carbon-Dioxide Fiber Optic Laser Cable874.45002EWG1SN
41ENTBronchoscope Biopsy Forceps (Nonrigid)874.46802BWH3CN
42ENTBronchoscope Biopsy Forceps (Rigid)874.46802JEK1CN
43Gastro/UrologyBiopsy Forceps Cover876.10751FFF1CY
44Gastro/UrologyBiopsy Instrument876.10752KNW3CN
45Gastro/UrologyBiopsy Needle Set876.10752FCG3CN
46Gastro/UrologyBiopsy Punch876.10752FCI2CN
47Gastro/UrologyMechanical Biopsy Instrument876.10752FCF2CN
48Gastro/UrologyNonelectric Biopsy Forceps876.10751FCL3CY
49Gastro/UrologyCytology Brush For Endoscope876.15002FDX2SN
50Gastro/UrologyEndoscope Accessories876.15002KOG2SN
51Gastro/UrologyExtraction Balloons/Baskets876.15002KOG2SN
52Gastro/UrologyEndoscopic Needle876.15002FBK3CN
53Gasro/UrologySimple Pneumoperitoneum Needle876.15002FHP3CN
54Gastro/UrologySpring Loaded Pneumoperitoneum Needle876.15002FHO3CN
55Gastro/UrologyActive Electrosurgical Electrode876.43002FAS3SN
56Gastro/UrologyBiliary Sphincterotomes876.5010, 876.15002FGE3CN
57Gastro/UrologyElectric Biopsy Forceps876.43002KGE3CN
58Gastro/UrologyElectrosurgical Endoscopic Unit (with or without accessories)876.43002KNS3SN
59Gastro/UrologyFlexible Snare876.43002FDI3SN
60Gastro/UrologyFlexible Suction Coagulator Electrode876.43002FEH3SN
61Gastro/UrologyFlexible Stone Dislodger876.46802FGO3SY
62Gastro/UrologyMetal Stone Dislodger876.46802FFL3SY
63Gastro/UrologyNeedle Holder876.47301FHQ1CY
64Gastro/UrologyNonelectrical Snare876.47301FGX1SY
65Gastro/UrologyUrological Catheter876.51302KOD2SN
66Gastro/UrologySingle Needle Dialysiss Set876.55402LBW, FIE3CN
67Gastro/UrologyHemodialysis Blood Circuit Accessories876.58202KOC2SN
68Gastro/UrologySingle Needle Dialysis Set876.58202FIF3CN
69Gastro/UrologyHemorrhoidal Ligator876.44002FHN2CN
70General HospitalImplanted Programmable Infusion PumpPost Amendment3LKK3CN
71General HospitalNeedle Destruction DevicePost Amendment3MTV1NN
72General HospitalNonpowered Flotation Therapy Mattress880.51501IKY2NY
73General HospitalNonAC-Powered Patient Lift880.55101FSA2NY
74General HospitalAlternating Pressure Air Flotation Mattress880.55502FNM1NY
75General HospitalTemperature Regulated Water Mattress880.55601FOH2NY
76General HospitalHypodermic Single Lumen Needle880.55702FMI3CN
77General HospitalPiston Syringe880.58602FMF3CN
78General HospitalMattress Cover (Medical Purposes)880.61901FMW2NY
79General HospitalDisposable Medical Scissors880.68201JOK1NY
80General HospitalIrrigating Syringe880.69601KYZ, KYY1CY
81Infection ControlSurgical Gowns878.40402FYA1CN
82LabBlood Lancet878.48001FMK1CY
83NeurologyClip Forming/Cutting Instrument882.41901HBS3*CY
84NeurologyDrills, Burrs, Trephines & Accessories (Manual)882.43002HBG3*CN
85NeurologyDrills, Burrs, Trephines & Accessories (Compound, Powered)882.43052HBF3*CN
86NeurologyDrills, Burrs, Trephines & Accessories (Simple, Powered)882.43102HBE3*CN
87OB/GYNOocyte Aspiration Needle 3MHK3CN
88OB/GYNLaparoscope Accessories884.17201HET2CY
89OB/GYNLaparoscope Accessories884.17202HET3CN
90OB/GYNLaparoscopic Dissectors884.17201HET2CY
91OB/GYNLaparoscopic Graspers884.17201HET2CY
92OB/GYNLaparoscopic Scissors884.17201HET2CY
93OB/GYNInsufflator Accessories (Tubing, Verres Needle, Kits)884.17302HIF3CY
94OB/GYNLaparoscopic Insufflator884.17302HIF2NN
95OB/GYNEndoscopic Electrocautery and Accessories884.41002HIM2NN
96OB/GYNGynecologic Electrocautery (and Accessories)884.41202HGI2NN
97OB/GYNEndoscopic Bipolar Coagulator-Cutter (and Accessories)884.41502HIN2NN
98OB/GYNCuldoscopic Coagulator (and Accessories)884.41602HFI2NN
99OB/GYNEndoscopic Unipolar Coagulator-Cutter (and Accessories)884.41602KNF2NN
100OB/GYNHysteroscopic Coagulator (and Accessories)884.41602HFH2NN
101OB/GYNUnipolar Laparoscopic Coagulator (and Accessories)884.41602HFG2NN
102OB/GYNEpisiotomy Scissors884.45201HDK1CY
103OB/GYNUmbilical Scissors884.45201HDJ1CY
104OB/GYNBiopsy Forceps884.45301HFB3CY
105OB/GYNAssisted Reproduction Needle884.61002MQE3CN
106OphthalmicEndoilluminator876.15002MPA3*CN
107OphthalmicSurgical Drapes878.43702KKX2CN
108OphthalmicOphthalmic Knife886.43501HNN3CY
109OphthalmicKeratome Blade886.43701HMY, HNO3CN
110OphthalmicPhacoemulsification Needle886.46702HQC3CN
111OphthalmicPhacoemulsification/ Phacofragmentation Fluidic886.46702MUS2CN
112OphthalmicPhacofragmentation Unit886.46702HQC1NN
113OrthopedicSaw Blades878.48201GFA, DWH, GEY, GET1CY
114OrthopedicSurgical Drills878.48201GEY, GET1CY
115OrthopedicArthroscope Accessories888.11002HRX2CY
116OrthopedicBone Tap888.45401HWX1CY
117OrthopedicBurr888.45401HTT1CY
118OrthopedicCarpal Tunnel Blade888.45401LXH2CY
119OrthopedicCountersink888.45401HWW1CY
120OrthopedicDrill Bit888.45401HTW1CY
121OrthopedicKnife888.45401HTS1CY
122OrthopedicManual Surgical Instrument888.45401LXH1CY
123OrthopedicNeedle Holder888.45401HXK1CY
124OrthopedicReamer888.45401HTO1CY
125OrthopedicRongeur888.45401HTX1CY
126OrthopedicScissors888.45401HRR1CY
127OrthopedicStaple Driver888.45401HXJ1CY
128OrthopedicTrephine888.45401HWK1CY
129OrthopedicFlexible Reamers/Drills886.4070/ 878.48201GEY, HRG1CY
130OrthopedicExternal Fixation Frame888.3040/ 888.30302JEC, KTW, KTT2NN
131Physical MedicineNonheating Lamp for Adjunctive Use Inpatient Therapy890.55002NHN1NN
132Physical MedicineElectrode Cable890.11752IKD1NY
133Physical MedicineExternal Limb Component, Hip Joint890.34201ISL2NY
134Physical MedicineExternal Limb Component, Knee Joint890.34201ISY2NY
135Physical MedicineExternal Limb Component, Mechanical Wrist890.34201ISZ2NY
136Physical MedicineExternal Limb Component, Shoulder Joint890.34201IQQ2NY
137Plastic SurgeryStapler878.48001GAG, GEF, FHM, HBT2CY
138RadiologyIsotope Needle892.57302IWF3CN
139RespiratoryEndotracheal Tube ChangerUnclassified3LNZ3CN
140RespiratoryAnesthesia Conduction Needle868.51502BSP3CN
141RespiratoryShort Term Spinal Needle868.51502MIA3CN
142RespiratoryRespiratory Therapy and Anesthesia Breathing Circuits868.52401CAI2SY
143RespiratoryOral and Nasal Catheters868.53501BZB1CY
144RespiratoryGas Masks868.55501BSJ1SY
145RespiratoryBreathing Mouthpiece868.56201BYP1NY
146RespiratoryTracheal Tube868.57302BTR3CN
147RespiratoryAirway Connector868.58101BZA2SY
148RespiratoryCPAP Mask868.59052BZD3SN
149RespiratoryEmergency Manual Resuscitator868.59152BTM2SN
150RespiratoryTracheobronchial Suction Catheter868.68101BSY3SY
151SurgeryAC-Powered Orthopedic Instrument and Accessories878.48201HWE2CN
152SurgeryBreast Implant Mammary SizerUnclassified MRD1CN
153SurgeryUltrasonic Surgical InstrumentUnclassified LFL3CN
154SurgeryTrocar874.44201KAB, KBG, KCI3CY
155SurgeryEndoscopic Blades876.15002GCP, GCR2CN
156SurgeryEndoscopic Guidewires876.15002GCP, GCR1CN
157SurgeryInflatable External Extremity Splint878.39001FZF1NY
158SurgeryNoninflatable External Extremity Splint878.39101FYH1NY
159SurgeryCatheter Needle878.42001GCB3CY
160SurgeryImplantable Clip878.43002FZP3CN
161SurgeryElectrosurgical and Coagulation Unit with Accessories878.44002BWA2CN
162SurgeryElectrosurgical Apparatus878.44002HAM2CN
163SurgeryElectrosurgical Cutting & Coagulation Device & Accessories878.44002GEI, NUJ2 3CN
164SurgeryElectrosurgical Device878.44002DWG2CN
165SurgeryElectrosurgical Electrode878.44002JOS2CN
166SurgeryImplantable Staple, Clamp, Clip for Suturing Apparatus878.47502GDW3CN
167SurgeryPercutaneous Biopsy Device878.48001MJG3CY
168SurgeryGastro-Urology Needle878.48001FHR3CY
169SurgeryAspiration and Injection Needle878.48001GAA3CY
170SurgeryBiopsy Brush878.48001GEE1CY
171SurgeryBlood Lancet878.48001FMK1CY
172SurgeryBone Hook878.48001KIK1CY
173SurgeryCardiovascular Biopsy Needle878.48001DWO3CY
174SurgeryClamp878.48001GDJ1CY
175SurgeryClamp878.48001HXD1CY
176SurgeryCurette878.48001HTF1CY
177SurgeryDisposable Surgical Instrument878.48001KDC1CY
178SurgeryDisposable Vein Stripper878.48001GAJ1CY
179SurgeryDissector878.48001GDI1CY
180SurgeryForceps878.48001GEN2CY
181SurgeryForceps878.48001HTD2CY
182SurgeryGouge878.48001GDH1CY
183SurgeryHemostatic Clip Applier878.48001HBT2CY
184SurgeryHook878.48001GDG1CY
185SurgeryManual Instrument878.48001MDM, MDW1CY
186SurgeryManual Retractor878.48001GZW1CY
187SurgeryManual Saw and Accessories878.48001GDR, HAC1CY
188SurgeryManual Saw and Accessories878.48001HAC1CY
189SurgeryManual Surgical Chisel878.48001FZO1CY
190SurgeryMastoid Chisel878.48001JYD1CY
191SurgeryOrthopedic Cutting Instrument878.48001HTZ1CY
192SurgeryOrthopedic Spatula878.48001HXR1CY
193SurgeryOsteotome878.48001HWM1CY
194SurgeryRasp878.48001GAC1CY
195SurgeryRasp878.48001HTR1CY
196SurgeryRetractor878.48001GAD1CY
197SurgeryRetractor878.48001HXM1CY
198SurgerySaw878.48001HSO1CY
199SurgeryScalpel Blade878.48001GES1CY
200SurgeryScalpel Handle878.48001GDZ1CY
201SurgeryScissors878.48001LRW1CY
202SurgerySnare878.48001GAE1CY
203SurgerySpatula878.48001GAF1CY
204SurgeryStaple Applier878.48001GEF2CY
205SurgeryStapler878.48001GAG2CY
206SurgeryStomach and Intestinal Suturing Apparatus878.48001FHM2CY
207SurgerySurgical Curette878.48001FZS1CY
208SurgerySurgical Cutter878.48001FZT1CY
209SurgerySurgical Knife878.48001EMF1SY
210SurgeryLaser Powered Instrument878.48102GEX2CN
211SurgeryAC-Powered Motor878.48201GEY2CY
212SurgeryBit878.48201GFG1CY
213SurgeryBur878.48201GFF, GEY1CY
214SurgeryCardiovascular Surgical Saw Blade878.48201DWH1CY
215SurgeryChisel (Osteotome)878.48201KDG1CY
216SurgeryDermatome878.48201GFD1CY
217SurgeryElectrically Powered Saw878.48201DWI2CY
218SurgeryPneumatic Powered Motor878.48201GET2CY
219SurgeryPneumatically Powered Saw878.48201KFK2CY
220SurgeryPowered Saw & Accessories878.48201HAB2CY
221SurgerySaw Blade878.48201GFA1CY
222SurgeryNonpneumatic Tourniquet878.59001GAX1NY
223SurgeryPneumatic Tourniquet878.59101KCY1NY
224SurgeryEndoscopic Staplers888.45401HXJ2CY
225SurgeryTrocar876.1500/ 870.13902GCJ, DRC3CN
226SurgerySurgical Cutting Accessories878.4800/ 874.44201GDZ, GDX, GES, KBQ, KAS2CY
227SurgeryElectrosurgical Electrodes/Handles/ Pencils876.4300/ 878.44002HAM, GEI, GAS2CN
228SurgeryScissor Tips878.4800/ 884.4520/ 874.44201LRW, HDK, HDJ, JZB, KBD2CY
229SurgeryLaser Fiber Delivery Systems878.4810/ 874.4500/ 886.4390/ 884.45502GEX, EWG, LLW, HQF, HHR, HQB1CN

\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.