FAT
8 FDA 510(k) clearances · Product code
163 daysmedian time to decision
263 days90th percentile
8clearances measured
FDA profile
- Official device name
- Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1999: 2 · 2000: 2 · 2001: 1 · 2002: 1 · 2004: 1 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PILLING ESOPHAGEAL BOUGIES (K133439) | Teleflexmedical, Inc. | 2014-06-16 |
| STRYKER INFRAVISION ESOPHAGEAL KIT (K983220) | Stryker Endoscopy | 1999-06-04 |
| MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (K972119) | Medovations, Inc. | 1998-02-02 |
| INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (K960173) | Gabriel Medical, Inc. | 1996-06-27 |
| PYLORIC BALLOON DILATOR (K901425) | Telemed Systems, Inc. | 1990-06-21 |
| ESKA MULTISTAGE ESOPHAGEAL BOUGIE (K843186) | Dacomed Corp. | 1985-01-18 |
| ESOPHAGEAL DILATOR SET (K842679) | Mill-Rose Laboratory | 1984-10-02 |
| GASTRIC LAVAGE KIT (K780471) | Gaymar Industries, Inc. | 1978-06-02 |
Track FAT automatically
Every clearance here is in the API, with alerts when new ones post.