EXI
7 FDA 510(k) clearances · Product code
100 daysmedian time to decision
272 days90th percentile
7clearances measured
FDA profile
- Official device name
- Device, Paste-On For Incontinence, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2001: 1
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 |
|---|---|---|
| FEMALE EXTERNAL URINARY COLLECTION POUCH (K971499) | Mediquest, Inc. | 1997-08-28 |
| HOLLISTER RETRACTED PENIS POUCH (K970443) | Hollister, Inc. | 1997-02-25 |
| BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950) | Bioderm, Inc. | 1997-01-10 |
| HOLLISTER PREMIUM URINE COLLECTOR (K931277) | Hollister, Inc. | 1993-06-23 |
| CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (K924755) | Convatec, A Division of E.R. Squibb & Sons | 1993-06-22 |
| CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (K915246) | Coloplast A/S | 1992-02-05 |
| URIHESIVE STRIP (K915616) | Convatec, A Division of E.R. Squibb & Sons | 1992-01-23 |
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Every clearance here is in the API, with alerts when new ones post.