HGI — Electrocautery, Gynecologic (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HGI
Device Class
Class II
Regulation Number
884.4120
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202915liger medicalIRIS Thermocoagulator and Digital ColposcopeApril 23, 2021
K152843liger medicalLiger Medical HTU-110June 24, 2016
K130606domain surgicalFMWAND FERROMAGNETIC SURGICAL SYSTEMJanuary 3, 2014
K121881domain surgicalDOMAIN SURGICAL SYSTEMOctober 18, 2012
K070877modern medical equipment mfgENDOCERVICAL ELECTRODE # 2July 27, 2007
K061651apple medicalFISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158October 20, 2006
K022593thomas medicalTHOMAS MEDICAL ELECTRODESNovember 1, 2002
K003608aesculapSOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGYFebruary 20, 2001
K002042new england medicalTRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018February 1, 2001
K993527palm medical usaLOOP ELECTRODE, BALL ELECTRODEJuly 6, 2000
K993777r-group intlDISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESMay 25, 2000
K983840wallach surgical devicesWALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)May 20, 1999
K982739gynexGYNEX ELECTRODESMarch 12, 1999
K974138a and a medicalROCKET ELECTRODEJanuary 30, 1998
K971986valley forge scientificVALLEY FORGE BIPOLAR LOOPAugust 26, 1997
K965245utah medical productsTBDJuly 3, 1997
K963653wallach surgical devicesWALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEMJune 11, 1997
K963348wallach surgical devicesWALLACH INTEGRATION UNITMarch 19, 1997
K963852karl storz endoscopy-americaKSEA THERMOCOAGULATOR (MODEL 265100 20)December 10, 1996
K955756karl storz endoscopy-americaKARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATORNovember 26, 1996