FGS

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Carrier, Sponge, Endoscopic

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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