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FDA product codes

The device classification tree, in product code order.

FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.

Data as of , the FDA export date. FDA product classification database

Review panels

6,880 codes
FDA review panels and the number of ingested product codes in each
Review panelPanel codeProduct codes
AnesthesiologyAN262
CardiovascularCV437
Clinical ChemistryCH527
Clinical ToxicologyTX338
DentalDE352
Ear, Nose, ThroatEN269
Gastroenterology, UrologyGU614
General HospitalHO394
General, Plastic SurgerySU562
HematologyHE281
ImmunologyIM278
Medical GeneticsMG7
MicrobiologyMI554
NeurologyNE291
Obstetrics/GynecologyOB269
OphthalmicOP345
OrthopedicOR349
PathologyPA325
Physical MedicinePM210
RadiologyRA216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 15 of 71
FDA product codes, page 15 of 71
CodeDevice nameClassRegulationClearancesRecalls
FZFSplint, Extremity, Inflatable, ExternalClass I21 CFR 878.390070
FZGApparatus, Air Handling, BenchClass II21 CFR 878.507010
FZHApparatus, Air Handling, RoomClass II21 CFR 878.507040
FZIApparatus, Air Handling, EnclosureClass II21 CFR 878.507050
FZKChair, Surgical, Non-ElectricalClass I21 CFR 878.495020
FZMStool, Operating-RoomClass I21 CFR 878.495011
FZOChisel, Surgical, ManualClass I21 CFR 878.480021
FZPClip, ImplantableClass II21 CFR 878.430017845
FZQClip, Removable (Skin)Class I21 CFR 878.432060
FZRContractor, SurgicalClass I21 CFR 878.480000
FZSCurette, Surgical, General UseClass I21 CFR 878.4800143
FZTCutter, SurgicalClass I21 CFR 878.4800526
FZWExpander, Surgical, Skin GraftClass I21 CFR 878.480089
FZXGuide, Surgical, InstrumentClass I21 CFR 878.48001929
FZYHammer, SurgicalClass I21 CFR 878.480012
FZZMarker, SkinClass I21 CFR 878.4660232
GAANeedle, Aspiration And Injection, DisposableClass I21 CFR 878.480010736
GABNeedle, Suturing, DisposableClass I21 CFR 878.480087
GACRasp, Surgical, General & Plastic SurgeryClass I21 CFR 878.480021
GADRetractorClass I21 CFR 878.480010044
GAESnare, SurgicalClass I21 CFR 878.480043
GAFSpatula, Surgical, General & Plastic SurgeryClass I21 CFR 878.480051
GAGStapler, SurgicalClass II21 CFR 878.47404310
GAHStylet, Surgical, General & Plastic SurgeryClass I21 CFR 878.480073
GAIStripper, Vein, ReusableClass I21 CFR 878.480000
GAJStripper, Vein, DisposableClass I21 CFR 878.480000
GAKSuture, AbsorbableClass II21 CFR 878.483010
GALSuture, Absorbable, NaturalClass II21 CFR 878.4830305
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidClass II21 CFR 878.4493149130
GANSuture, Absorbable, SyntheticClass II21 CFR 878.483072
GAOSuture, NonabsorbableClass II21 CFR 878.449541
GAPSuture, Nonabsorbable, SilkClass II21 CFR 878.50304128
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileClass II21 CFR 878.4495326
GARSuture, Nonabsorbable, Synthetic, PolyamideClass II21 CFR 878.50205714
GASSuture, Nonabsorbable, Synthetic, PolyesterClass II21 CFR 878.5000171
GATSuture, Nonabsorbable, Synthetic, PolyethyleneClass II21 CFR 878.500017623
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneClass II21 CFR 878.50108528
GAXTourniquet, NonpneumaticClass I21 CFR 878.5900208
GAZTubing, NoninvasiveClass II21 CFR 880.67402714
GBACatheter, Balloon TypeClass I21 CFR 878.420051
GBBChair, Surgical, Ac-PoweredClass I21 CFR 878.496081
GBCLamp, Surgical, IncandescentClass II21 CFR 878.458040
GBIMaterial, External Aesthetic Restoration, Used With AdhesiveClass I21 CFR 878.3800170
GBJProsthesis, Adhesive, ExternalClass I21 CFR 878.375040
GBLCatheter, Ureteral, General & Plastic SurgeryNot classified21 CFR 876.513002
GBMCatheter, UrethralClass II21 CFR 876.51307118
GBNCatheter, Pediatric, General & Plastic SurgeryClass I21 CFR 878.420021
GBOCatheter, Nephrostomy, General & Plastic SurgeryClass I21 CFR 878.4200118
GBPCatheter, Multiple LumenClass I21 CFR 878.420030
GBQCatheter, Continuous IrrigationClass I21 CFR 878.420081
GBSCatheter, Ventricular, General & Plastic SurgeryClass I21 CFR 878.42002720
GBTCatheter, RectalClass II21 CFR 876.598031
GBWCatheter, PeritonealClass I21 CFR 878.42001715
GBXCatheter, IrrigationClass I21 CFR 878.42007782
GBYCatheter, Eustachian, General & Plastic SurgeryClass I21 CFR 878.420000
GBZCatheter, CholangiographyClass I21 CFR 878.42002427
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionClass II21 CFR 876.5010262
GCBNeedle, CatheterClass I21 CFR 878.420088
GCCDilator, CatheterClass I21 CFR 878.420055
GCDConnector, CatheterClass I21 CFR 878.420087
GCEAdaptor, CatheterClass I21 CFR 878.420040
GCFProctoscopeClass II21 CFR 876.150021
GCGPeritoneoscopeClass II21 CFR 876.150000
GCHMediastinoscope, DiagnosticClass II21 CFR 876.150000
GCILaryngoscope, EndoscopeClass II21 CFR 876.1500145
GCJLaparoscope, General & Plastic SurgeryClass II21 CFR 876.15001,430274
GCKGastroscope, General & Plastic SurgeryClass II21 CFR 876.150001
GCLEsophagoscope, General & Plastic SurgeryClass II21 CFR 876.150040
GCMEndoscope, RigidClass II21 CFR 876.1500180
GCNEndoscope, PrismClass II21 CFR 876.150000
GCOEndoscope, MirrorClass II21 CFR 876.150030
GCPEndoscope, Ac-Powered And AccessoriesClass II21 CFR 876.1500135
GCQEndoscope, FlexibleClass II21 CFR 876.1500522
GCSEndoscope, Battery-Powered And AccessoriesClass II21 CFR 876.150090
GCTLight Source, Endoscope, Xenon ArcClass II21 CFR 876.1500473
GCWTransformer, EndoscopeClass II21 CFR 876.150016
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredClass II21 CFR 880.67408738
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredClass I21 CFR 878.468096107
GCZRetainer, SurgicalClass I21 CFR 878.480056
GDBEndoscope, Fiber OpticClass II21 CFR 876.150070
GDCTable, Operating-Room, ElectricalClass I21 CFR 878.49601827
GDFGuide, Needle, SurgicalClass I21 CFR 878.48002820
GDGHook, Surgical, General & Plastic SurgeryClass I21 CFR 878.4800107
GDHGouge, Surgical, General & Plastic SurgeryClass I21 CFR 878.480060
GDIDissector, Surgical, General & Plastic SurgeryClass I21 CFR 878.480076
GDJClamp, Surgical, General & Plastic SurgeryClass I21 CFR 878.4800329
GDLNeedle, Suturing, ReusableClass I21 CFR 878.480050
GDMNeedle, Aspiration And Injection, ReusableClass I21 CFR 878.4800484
GDNKnife, AmputationClass I21 CFR 878.480010
GDOApplier, Surgical, ClipClass I21 CFR 878.4800148
GDRSaw, Manual And AccessoriesClass I21 CFR 878.480021
GDSBag, StomalClass I21 CFR 876.590023
GDTStaple, Removable (Skin)Class I21 CFR 878.4760195
GDWStaple, ImplantableClass II21 CFR 878.4750284225
GDXScalpel, One-PieceClass I21 CFR 878.4800266
GDYGauze/Sponge, Internal, X-Ray DetectableClass I21 CFR 878.445011166
GDZHandle, ScalpelClass I21 CFR 878.48001613
GEACannula, Surgical, General & Plastic SurgeryClass I21 CFR 878.48003624
GECBrush, Scrub, Operating-RoomClass I21 CFR 878.4800370
GEDBrush, Dermabrasion, ManualClass I21 CFR 878.480020