Atlas FDA

FHG

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Bell, Circumcision
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2005: 2 · 2006: 2 · 2007: 4 · 2008: 2 · 2009: 5 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (K911272)Edward Weck, Inc.1991-07-02
CIRCUMCISION KIT (K770873)American Hospital Supply Corp.1977-07-11

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Every clearance here is in the API, with alerts when new ones post.