HIN — Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HIN
Device Class
Class II
Regulation Number
884.4150
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142525olympus winter and ibePK Lap LoopNovember 21, 2014
K130305lina medical apsLINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZEJuly 24, 2013
K122983karl storz endoscopy-americaKSEA BIPOLAR ELECTRODEJune 26, 2013
K122605gyrus acmiPKS BILLDecember 5, 2012
K113080mectra labsTUBALGATORJune 29, 2012
K111751ethiconVERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP EDecember 2, 2011
K111059gyrus acmiGYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)September 1, 2011
K990147richard wolf medical instrumentsBIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.77April 16, 1999
K971565everest medicalBICOAG COAGULATING FORCEPSMarch 12, 1998
K926517elmedELMED LBC 50-PNovember 15, 1994
K943776richard wolf medical instrumentsCOAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIESNovember 3, 1994
K911699surgical technologiesSTI TISSUE MANIPULATORJune 13, 1991
K871745karl storz endoscopy-americaMODEL 26021C BIPOLAR COAGULATORJuly 10, 1987
K790043neomedTRACOR, CANNULA, BICEPTS BIPOLARFebruary 8, 1979
K781109kliFORCEPS, ELECTROSURGICALSeptember 14, 1978
K781089kliONE INCISION BI-POLAR ELECTRO. FORCEPSJuly 17, 1978