FDA 510(k) Applications for Medical Device Product Code "HIN"
(Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))

FDA 510(k) Number Applicant Device Name Decision Date
K111751 ETHICON, INC. VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS 12/02/2011
K971565 EVEREST MEDICAL CORP. BICOAG COAGULATING FORCEPS 03/12/1998
K111059 GYRUS ACMI, INC. GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) 09/01/2011
K122605 GYRUS ACMI, INC. PKS BILL 12/05/2012
K122983 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA BIPOLAR ELECTRODE 06/26/2013
K130305 LINA MEDICAL APS LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE 07/24/2013
K113080 MECTRA LABS, INC. TUBALGATOR 06/29/2012
K142525 Olympus Winter & Ibe GmbH PK Lap Loop 11/21/2014
K990147 RICHARD WOLF MEDICAL INSTRUMENTS CORP. BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 04/16/1999


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