FFI

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Alarm, Electrosurgical

Device class

Class II (moderate risk)

Regulation

21 CFR 876.4300

Medical specialty

Gastroenterology, Urology

Flags

Third-party review eligible

Adverse events (MAUDE)

1993: 1
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