Panels › Gastroenterology, Urology › Product code FDE · Class 2

Laparoscopy Kit

Regulation 876.1500

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

22recalls in 12 months (127 all time)

1recalls that name a 510(k)

Top companies in FDE

Company	510(k)s	Recalls
Customed, Inc	0	59
MEDLINE INDUSTRIES, LP - Northfield	0	23
Medline Industries Inc	0	21
American Contract Systems	0	15
ROi CPS LLC	0	4
Cardinal Health 200, LLC	0	2
Aslan Medical Technologies, Ltd.	1	0
Boston Scientific Corp	1	0
Candela Laser Corp.	1	0
DeRoyal Industries Inc	0	1

Decided	510(k)	Device and applicant	Code
Apr 18, 1996	K955717	ENDOSCOPE INTRODUCER KIT Mitsubishi Cable America, Inc.	FDE
Mar 14, 1995	K950924	ASLAN KNOT PUSHER Aslan Medical Technologies, Ltd.	FDE
Jul 21, 1994	K942677	GEENEN/ZEBRA GUIDELINES Boston Scientific Corp	FDE
Aug 16, 1991	K912443	CANDELA INTRODUCER SHEATH SYSTEM Candela Laser Corp.	FDE

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