FHO

15 FDA 510(k) clearances · Product code

FDA profile

Official device name

Pneumoperitoneum Needle

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Flags

Third-party review eligible

FDA definition

For establishment of a pneumoperitoneum in abdomen.

Adverse events (MAUDE)

2002: 2 · 2004: 2 · 2005: 2 · 2006: 5 · 2007: 2 · 2017: 10
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