FHM

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Apparatus, Suturing, Stomach And Intestinal

Device class

Class I (low risk)

Regulation

21 CFR 878.4800

Medical specialty

General, Plastic Surgery

Adverse events (MAUDE)

1992: 1 · 1993: 2 · 1994: 3 · 2000: 1 · 2008: 3 · 2009: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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