Atlas FDA

GCO

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Endoscope, Mirror
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
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RecordFirmDate
CYTOTECH HSV IGG ENZYME IMMUNOASSAY (K862838)Cytotech, Inc.1986-12-09
HAND MIRROR (ENDOSCOPE) (K862717)Simpson/Basye, Inc.1986-07-30
DELTA-ROL (K790340)Johnson & Johnson Professionals, Inc.1979-04-12

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