PJH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dynamic Rectal Control System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5930
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Eclipse System (K150558) | Pelvalon, Inc. | 2015-11-12 |
| ECLIPSE SYSTEM (DEN140020) | Pelvalon | 2015-02-12 |
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