GDS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bag, Stomal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 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 |
|---|---|---|
| MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND (K883023) | Mentor Corp. | 1988-09-29 |
| ULTRA-FRESH DEODORANT (K871313) | Mentor Corp. | 1988-03-02 |
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Every clearance here is in the API, with alerts when new ones post.