EXF
9 FDA 510(k) clearances · Product code
69 daysmedian time to decision
296 days90th percentile
9clearances measured
FDA profile
- Official device name
- Bag, Bile Collecting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1997: 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 |
|---|---|---|
| MERIT DRAINAGE DEPOT (K003078) | Merit Medical Systems, Inc. | 2000-12-11 |
| DRAINAGE BAG (K990428) | Remington Medical, Inc. | 1999-08-12 |
| MANAN D BAG (K980005) | Medical Device Technologies, Inc. | 1998-01-30 |
| MANAN D BAG (K961986) | Manan Medical Products, Inc. | 1997-03-13 |
| MANAN D BAG (K963849) | Manan Medical Products, Inc. | 1996-12-13 |
| NAVARRE 600 ML DRAINAGE BAG (K943663) | Navarre Biomedical , Ltd. | 1994-09-08 |
| MMG BILE BAG (K911129) | Medical Technologies of Georgia | 1991-08-07 |
| URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (K903449) | Uresil Corp. | 1990-09-12 |
| URESIL TRU-CLOSE DRAINAGE BAG (K901844) | Uresil Corp. | 1990-06-01 |
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Every clearance here is in the API, with alerts when new ones post.