FGF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Catheter, Ureteral Disposable (X-Ray)

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5130

Medical specialty

Gastroenterology, Urology

Flags

Third-party review eligible

Adverse events (MAUDE)

2000: 3 · 2001: 1 · 2002: 2 · 2003: 1 · 2005: 2 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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