Panels › Obstetrics/Gynecology › Product code HGI · Class 2

Electrocautery, Gynecologic (And Accessories)

Regulation 884.4120

0510(k)s in 12 months (53 all time)

0recalls in 12 months (24 all time)

23recalls that name a 510(k)

Top companies in HGI

Company	510(k)s	Recalls
CooperSurgical, Inc.	1	14
Apple Medical Corp.	2	8
Wallach Surgical Devices, Inc.	5	0
Utah Medical Products, Inc.	4	0
Valleylab, Inc.	3	0
Aaron Medical Industries	2	0
Aspen Labs	2	0
Cabot Medical Corp.	2	0
Cameron-Miller, Inc.	2	0
Domain Surgical, Inc.	2	0

Decided	510(k)	Device and applicant	Code
Apr 26, 1990	K895402	ENDOCOAGULATOR 2001 KLI Cabot Medical Corp.	HGI
Mar 9, 1977	K770295	ABDOMINAL ECG PROCESSOR FOR FETAL MONI. Brattle Instrument Corp.	HGI
Mar 9, 1977	K770292	MONITOR, FETAL HEART, MODEL 1980 Berkeley Bio-Engineering	HGI

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