FGD
6 FDA 510(k) clearances · Product code
171 daysmedian time to decision
406 days90th percentile
6clearances measured
FDA profile
- Official device name
- Catheter, Retention, Barium Enema With Bag
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 3 · 1994: 1 · 1995: 2 · 2000: 2 · 2004: 1 · 2008: 2
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 |
|---|---|---|
| NAJA Gastrointestinal Catheter (K223890) | Chess Medical, Inc. | 2023-06-16 |
| DUAL FLEX NON-LATEX (K905026) | Mmi, Inc. | 1991-12-18 |
| SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (K905574) | E-Z-Em, Inc. | 1991-01-24 |
| SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF (K904299) | E-Z-Em, Inc. | 1990-11-27 |
| MAGLINTE ENTEROCLYSIS CATHETER (K884379) | Lafayette Pharmacal, Inc. | 1989-02-28 |
| DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (K872006) | Mac Lee Medical Products | 1987-11-17 |
Track FGD automatically
Every clearance here is in the API, with alerts when new ones post.