EYZ

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Device class

Class I (low risk)

Regulation

21 CFR 876.5250

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

2001: 1 · 2002: 9 · 2003: 7 · 2004: 1 · 2005: 3 · 2006: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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