EZS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Appliance, Colostomy, Disposable

Device class

Class I (low risk)

Regulation

21 CFR 876.5900

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

2000: 3 · 2003: 2 · 2005: 9 · 2007: 3 · 2008: 2 · 2013: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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