ClearanceBrief
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)
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Top companies in HGI

Company510(k)sRecalls
CooperSurgical, Inc.114
Apple Medical Corp.28
Wallach Surgical Devices, Inc.50
Utah Medical Products, Inc.40
Valleylab, Inc.30
Aaron Medical Industries20
Aspen Labs20
Cabot Medical Corp.20
Cameron-Miller, Inc.20
Domain Surgical, Inc.20
DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
Open, Classified		 HGIK061651
Sep 29, 2021CooperSurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Open, Classified		 HGIK963653
Sep 29, 2021CooperSurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
Open, Classified		 HGIK963653
Sep 29, 2021CooperSurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Open, Classified		 HGIK963653
Sep 29, 2021CooperSurgical, Inc.
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Open, Classified		 HGIK963653
Sep 29, 2021CooperSurgical, Inc.
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
Open, Classified		 HGIK963653
Sep 29, 2021CooperSurgical, Inc.
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Open, Classified		 HGIK963348
Sep 29, 2021CooperSurgical, Inc.
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
Open, Classified		 HGIK963348
Oct 16, 2019CooperSurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
Terminated		 HGIK963653
Oct 16, 2019CooperSurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075-05.
Terminated		 HGIK963653
Oct 16, 2019CooperSurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075.
Terminated		 HGIK963653
Jun 18, 2019CooperSurgical, Inc.
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Terminated		 HGIK963348
K963653
Apr 23, 2019CooperSurgical, Inc.
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEE
Terminated		 HGIK963348
Mar 12, 2018CooperSurgical, Inc.
Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Terminated		 HGIK061651
Dec 2, 2014CooperSurgical, Inc.
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions
Terminated		 HGIK905747
Oct 3, 2012Gynex Corporation
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activ
Terminated		 HGINone listed
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor Model: 900-158
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor Model: 900-157
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Large Model: 900-152
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Medium Model: 900-151
Terminated		 HGIK961460
Apr 6, 2006Apple Medical Corporation
Fischer Cone Biopsy Excisor - Small Model: 900-150
Terminated		 HGIK961460

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