FCE

30 FDA 510(k) clearances · Product code

FDA profile

Official device name

Enema Kit

Device class

Class I (low risk)

Regulation

21 CFR 876.5210

Medical specialty

Gastroenterology, Urology

Flags

GMP exempt

FDA definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Adverse events (MAUDE)

2002: 1 · 2003: 4 · 2005: 2 · 2007: 2 · 2008: 3 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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