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510(k) K952483

Device
LEEP SYSTEM 1000
Applicant
COOPERSURGICAL, INC.
510(k) number
K952483
Product code
HGI  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-06
Date received
1995-05-30
Regulation
884.4120
Classification name
Electrocautery, Gynecologic (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHEILA HEMEON-HEYER
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC2021-04-23
K152843Liger Medical HTU-110Liger Medical, LLC2016-06-24
K130606FMWAND FERROMAGNETIC SURGICAL SYSTEMDomain Surgical, Inc.2014-01-03
K121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.2012-10-18
K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.2007-07-27
K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.2006-10-20
K022593THOMAS MEDICAL ELECTRODESThomas Medical, Inc.2002-11-01
K003608SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGYAesculap, Inc.2001-02-20
K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018New England Medical Corp.2001-02-01
K993527LOOP ELECTRODE, BALL ELECTRODEPalm Medical USA, Inc.2000-07-06
K993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESR-Group Intl.2000-05-25
K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)Wallach Surgical Devices, Inc.1999-05-20
K982739GYNEX ELECTRODESGynex Corp.1999-03-12
K974138ROCKET ELECTRODEA & A Medical, Inc.1998-01-30
K971986VALLEY FORGE BIPOLAR LOOPValley Forge Scientific Corp.1997-08-26

Legacy Summary#

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FDA Review#

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