FHR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Needle, Gastro-Urology

Device class

Class I (low risk)

Regulation

21 CFR 878.4800

Medical specialty

General, Plastic Surgery

Adverse events (MAUDE)

1992: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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