FDA product code FAT: Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
FAT is the FDA product code for bougie, esophageal, and gastrointestinal, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under FAT, from 8 different applicants. The average 510(k) review took 160 days (median 160). FDA has posted 2 recalls for FAT devices.
Classification
| Field | Value |
|---|---|
| Device name | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.5365 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FAT clearance
Top FAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teleflexmedical, Inc. | 1 | 2014-06-16 |
| Stryker Endoscopy | 1 | 1999-06-04 |
| Medovations, Inc. | 1 | 1998-02-02 |
| Gabriel Medical, Inc. | 1 | 1996-06-27 |
| Telemed Systems, Inc. | 1 | 1990-06-21 |
3 more applicants have FAT clearances. See the full list in Caduvo.
Most recent FAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133439 | Teleflexmedical, Inc. | PILLING ESOPHAGEAL BOUGIES | 2014-06-16 | 216 |
| K983220 | Stryker Endoscopy | STRYKER INFRAVISION ESOPHAGEAL KIT | 1999-06-04 | 263 |
| K972119 | Medovations, Inc. | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | 1998-02-02 | 242 |
| K960173 | Gabriel Medical, Inc. | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | 1996-06-27 | 163 |
| K901425 | Telemed Systems, Inc. | PYLORIC BALLOON DILATOR | 1990-06-21 | 87 |
Recalls for FAT devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-11.
Frequently asked questions
What is FDA product code FAT?
FAT is the FDA product code for bougie, esophageal, and gastrointestinal, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5365 and reviewed by the Gastroenterology and Urology panel.
What device class is FAT?
Class II, regulation 21 CFR 876.5365. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FAT?
Across 8 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most FAT clearances?
Teleflexmedical, Inc. (1); Stryker Endoscopy (1); Medovations, Inc. (1); Gabriel Medical, Inc. (1); Telemed Systems, Inc. (1).
Have FAT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FAT
- Run a recall and safety report across every FAT manufacturer
- Watch product code FAT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times