Panels › Gastroenterology, Urology › Product code FEM · Class 1

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Regulation 876.1500

0510(k)s in 12 months (4 all time)

0recalls in 12 months (5 all time)

0recalls that name a 510(k)

Top companies in FEM

Company	510(k)s	Recalls
Polaroid Corp.	2	0
Smith And Nephew, Inc. Endoscopy Division	0	2
Ambu Inc.	0	1
Hydro-Med Products, Inc.	1	0
Olympus America Inc.	0	1
Olympus Corporation of the Americas	0	1
Reznik Instruments	1	0

Decided	510(k)	Device and applicant	Code
Oct 28, 1994	K940152	CAMERA COVER WITH TEAR TIP Hydro-Med Products, Inc.	FEM
Oct 19, 1981	K812542	POLAROID INSTANT ENDOCAMERA Polaroid Corp.	FEM
Oct 19, 1981	K812201	PHOTOGRAPHIC EQUIPMENT Reznik Instruments	FEM
Dec 20, 1979	K792512	POLAROID LAND CAMERA FOR ENDOSCOPY Polaroid Corp.	FEM

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