FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources) Class I

FDA Device Classification

FDA product code FEM covers "Accessories, Photographic, For Endoscope (Exclude Light Sources)", a Class I medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FEM
Device Class
Class I
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940152Hydro-Med ProductsCAMERA COVER WITH TEAR TIPOct 28, 1994
K812201Reznik InstrumentsPHOTOGRAPHIC EQUIPMENTOct 19, 1981
K812542PolaroidPOLAROID INSTANT ENDOCAMERAOct 19, 1981
K792512PolaroidPOLAROID LAND CAMERA FOR ENDOSCOPYDec 20, 1979