FCR

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Light Source, Photographic, Fiberoptic

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

1994: 1 · 1997: 3 · 2001: 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