FON
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bag, Drainage, With Adhesive, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2001: 2 · 2005: 3 · 2014: 6 · 2022: 13 · 2025: 69 · 2026: 35
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 |
|---|---|---|
| HOLLISTER DRAINAGE POUCH (K801504) | Hollister, Inc. | 1980-08-12 |
| BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (K772366) | Atlantic Surgical | 1978-01-26 |
| POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE (K770826) | Howmedica Corp. | 1977-06-28 |
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Every clearance here is in the API, with alerts when new ones post.