FHP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Needle, Pneumoperitoneum, Simple
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 5 · 1996: 3 · 1997: 1 · 1998: 4 · 2004: 1 · 2006: 2
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 VERESS NEEDLE (K910855) | Symbiosis Corp. | 1991-04-18 |
| MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (K860102) | Endotherapeutics | 1986-02-12 |
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Every clearance here is in the API, with alerts when new ones post.