FDP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Apparatus, Pneumoperitoneum, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 1 · 2009: 23 · 2010: 14 · 2015: 11 · 2024: 22
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 |
|---|---|---|
| ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE (K910875) | ETHICON, Inc. | 1991-03-19 |
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Every clearance here is in the API, with alerts when new ones post.