HIN · Class II · 21 CFR 884.4150

FDA Product Code HIN: Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Richard Wolf Medical Instruments Corp. and Gyrus Acmi, Inc..

16
Total
16
Cleared
163d
Avg days
1978
Since

FDA 510(k) Cleared Coagulator-cutter, Endoscopic, Bipolar (and Accessories) Devices (Product Code HIN)

16 devices
1–16 of 16
Cleared Nov 21, 2014
PK Lap Loop
K142525
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 74d
Cleared Jun 26, 2013
KSEA BIPOLAR ELECTRODE
K122983
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 273d
Cleared Dec 05, 2012
PKS BILL
K122605
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 02, 2011
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K111751
Ethicon, Inc.
Obstetrics & Gynecology · 163d
Cleared Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 136d
Cleared Apr 16, 1999
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
K990147
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d
Cleared Nov 03, 1994
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
K943776
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 93d
Cleared Jul 10, 1987
MODEL 26021C BIPOLAR COAGULATOR
K871745
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 66d

About Product Code HIN - Regulatory Context