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| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| EYY | Drape, Urological, Disposable | Class II | 21 CFR 878.4370 | 2 | 0 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Class I | 21 CFR 876.5250 | 14 | 1 |
| EZB | Stylet For Catheter, Gastro-Urology | Class I | 21 CFR 876.5130 | 3 | 13 |
| EZC | Catheter, Coude | Class II | 21 CFR 876.5130 | 7 | 11 |
| EZD | Catheter, Straight | Class II | 21 CFR 876.5130 | 87 | 13 |
| EZK | Catheter, Retention Type | Class II | 21 CFR 876.5980 | 3 | 0 |
| EZL | Catheter, Retention Type, Balloon | Class II | 21 CFR 876.5130 | 130 | 85 |
| EZM | Dilator, Esophageal (Metal Olive) Gastro-Urology | Class II | 21 CFR 876.5365 | 0 | 0 |
| EZN | Dilator, Catheter, Ureteral | Class II | 21 CFR 876.5470 | 56 | 14 |
| EZO | Urethrotome | Class II | 21 CFR 876.4770 | 5 | 1 |
| EZP | Rod, Colostomy | Class II | 21 CFR 876.4270 | 2 | 0 |
| EZQ | Pouch, Colostomy | Class I | 21 CFR 876.5900 | 6 | 5 |
| EZR | Cement, Stomal Appliance, Ostomy | Class I | 21 CFR 876.5900 | 6 | 0 |
| EZS | Appliance, Colostomy, Disposable | Class I | 21 CFR 876.5900 | 1 | 0 |
| EZT | Pacemaker, Bladder | Class III | 21 CFR 876.5270 | 0 | 0 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Class III | 21 CFR 876.5270 | 0 | 9 |
| EZX | Mesh, Surgical, Metal | Class II | 21 CFR 878.3300 | 12 | 1 |
| EZY | Device, Incontinence, Mechanical/Hydraulic | Class III | 21 CFR 876.5280 | 0 | 7 |
| EZZ | Prosthesis, Vas Deferens | Class III | 1 | 0 | |
| FAA | Replacer, Urethral | Class III | 1 | 0 | |
| FAB | Replacer, Ureteral | Class III | 0 | 0 | |
| FAC | Valve, Ureterovesicle | Class III | 0 | 0 | |
| FAD | Stent, Ureteral | Class II | 21 CFR 876.4620 | 122 | 55 |
| FAE | Prosthesis, Penile | Class II | 21 CFR 876.3630 | 32 | 3 |
| FAF | Prosthesis, Testicular | Class III | 21 CFR 876.3750 | 0 | 1 |
| FAG | Prosthesis, Urethral Sphincter | Class III | 2 | 0 | |
| FAH | Dilator, Urethral, Mechanical | Class II | 21 CFR 876.5520 | 4 | 0 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 92 | 22 |
| FAK | Panendoscope (Gastroduodenoscope) | Class II | 21 CFR 876.1500 | 2 | 0 |
| FAL | Panendoscope (Urethroscope) | Class II | 21 CFR 876.1500 | 1 | 0 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 24 | 2 |
| FAN | Sigmoidoscope, Rigid, Electrical | Class II | 21 CFR 876.1500 | 2 | 0 |
| FAO | Device, Cystometric, Air | Class III | 0 | 0 | |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | Class II | 21 CFR 876.1620 | 85 | 6 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Class I | 21 CFR 876.5250 | 18 | 7 |
| FAR | Unit, Electrosurgical | Class II | 21 CFR 876.4300 | 0 | 0 |
| FAS | Electrode, Electrosurgical, Active, Urological | Class II | 21 CFR 876.4300 | 58 | 9 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | Class II | 21 CFR 876.5365 | 8 | 2 |
| FAX | Bougie, Urological | Class I | 21 CFR 876.5520 | 2 | 0 |
| FAZ | System, Cryosurgical, Liquid Nitrogen, For Urology | Class II | 21 CFR 878.4350 | 0 | 0 |
| FBI | Rongeur, Cystoscopic | Class II | 21 CFR 876.1500 | 0 | 0 |
| FBJ | Cord, Electric For Transurethral Surgical Instrument | Class II | 21 CFR 876.4300 | 0 | 0 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | 21 CFR 876.1500 | 89 | 42 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Class I | 21 CFR 876.5090 | 9 | 0 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 43 | 9 |
| FBO | Cystourethroscope | Class II | 21 CFR 876.1500 | 19 | 7 |
| FBP | Telescope, Rigid, Endoscopic | Class II | 21 CFR 876.1500 | 5 | 0 |
| FBQ | Trocar, Gastro-Urology | Class II | 21 CFR 876.5090 | 9 | 25 |
| FBR | Urethrometer | Class I | 21 CFR 876.5520 | 0 | 1 |
| FBS | Sound, Metal, Interconnected | Class I | 21 CFR 876.4590 | 1 | 0 |
| FBW | Filiform And Filiform Follower | Class I | 21 CFR 876.5520 | 1 | 0 |
| FBX | Sound, Urethral, Metal Or Plastic | Class I | 21 CFR 876.5520 | 1 | 1 |
| FBY | Cooler, Esophageal And Gastric | Class III | 0 | 0 | |
| FBZ | Cooler, Prostatic | Class III | 0 | 0 | |
| FCB | Bag, Hemostatic | Class II | 21 CFR 876.5980 | 0 | 1 |
| FCC | Endoscopic Magnetic Retriever | Class II | 21 CFR 876.1500 | 3 | 0 |
| FCD | Barium Enema Kit | Class I | 21 CFR 876.5210 | 2 | 0 |
| FCE | Enema Kit | Class I | 21 CFR 876.5210 | 30 | 0 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | Class II | 21 CFR 876.1075 | 6 | 0 |
| FCG | Biopsy Needle | Class II | 21 CFR 876.1075 | 133 | 54 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | Class I | 21 CFR 876.4730 | 2 | 14 |
| FCI | Punch, Biopsy | Class II | 21 CFR 876.1075 | 5 | 0 |
| FCK | Instrument, Biopsy, Suction | Class II | 21 CFR 876.1075 | 13 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | Class I | 21 CFR 876.1075 | 39 | 11 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class II | 21 CFR 876.5130 | 60 | 43 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Class II | 21 CFR 876.5250 | 10 | 3 |
| FCO | Box, Battery, Rechargeable | Class I | 21 CFR 876.1500 | 20 | 0 |
| FCP | Box, Battery, Pocket | Class I | 21 CFR 876.1500 | 2 | 1 |
| FCQ | Light Source, Incandescent, Diagnostic | Class II | 21 CFR 876.1500 | 1 | 0 |
| FCR | Light Source, Photographic, Fiberoptic | Class II | 21 CFR 876.1500 | 3 | 0 |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | Class II | 21 CFR 876.4020 | 10 | 3 |
| FCT | Headlight, Fiberoptic Focusing | Class II | 21 CFR 886.4335 | 6 | 0 |
| FCW | Light Source, Fiberoptic, Routine | Class II | 21 CFR 876.1500 | 31 | 5 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | Class II | 21 CFR 876.1500 | 25 | 2 |
| FCY | Bulb, Inflation, For Endoscope | Class I | 21 CFR 876.1500 | 3 | 0 |
| FCZ | Tube, Smoke Removal, Endoscopic | Class I | 21 CFR 876.1500 | 0 | 0 |
| FDA | Enteroscope And Accessories | Class II | 21 CFR 876.1500 | 20 | 0 |
| FDB | Plate, Patient | Class II | 21 CFR 876.4300 | 0 | 0 |
| FDC | Resectoscope, Working Element | Class II | 21 CFR 876.1500 | 11 | 0 |
| FDE | Laparoscopy Kit | Class II | 21 CFR 876.1500 | 4 | 124 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 115 | 25 |
| FDG | Retractor, Fiberoptic | Class I | 21 CFR 876.4530 | 2 | 2 |
| FDI | Snare, Flexible | Class II | 21 CFR 876.4300 | 63 | 18 |
| FDJ | Snare, Rigid Self-Opening | Class II | 21 CFR 876.4300 | 0 | 0 |
| FDL | Wristlet, Patient Return | Class II | 21 CFR 876.4300 | 0 | 0 |
| FDP | Apparatus, Pneumoperitoneum, Automatic | Class II | 21 CFR 876.1500 | 1 | 0 |
| FDR | Sphyncteroscope | Class II | 21 CFR 876.1500 | 0 | 0 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 79 | 12 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | Class II | 21 CFR 876.1500 | 35 | 38 |
| FDW | Esophagoscope, Rigid, Gastro-Urology | Class II | 21 CFR 876.1500 | 0 | 0 |
| FDX | Endoscopic Cytology Brush | Class II | 21 CFR 876.1500 | 44 | 5 |
| FDY | Device, Measuring, For Panendoscope | Class I | 21 CFR 876.1500 | 0 | 0 |
| FDZ | Attachment, Eyepiece, For Insertion Of Prescription Lens | Class I | 21 CFR 876.1500 | 2 | 0 |
| FEA | Attachment, Teaching, For Endoscope | Class I | 21 CFR 876.1500 | 2 | 0 |
| FEB | Accessories, Cleaning, For Endoscope | Class II | 21 CFR 876.1500 | 57 | 40 |
| FEC | Obturator, For Endoscope | Class II | 21 CFR 876.1500 | 3 | 0 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | 21 CFR 876.1500 | 105 | 12 |
| FEF | Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression | Class II | 21 CFR 876.5980 | 1 | 0 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Class II | 21 CFR 876.5980 | 13 | 14 |
| FEH | Electrode, Flexible Suction Coagulator | Class II | 21 CFR 876.4300 | 3 | 0 |
