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

FDA 510(k) Number Applicant Device Name Decision Date
K971621 AARON MEDICAL INDUSTRIES RESISTICK SOLID LAPAROSCOPIC ELECTRODES 06/20/1997
K010752 AESCULAP, INC. AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY 06/11/2001
K121343 ATC TECHNOLOGIES, INC. MODULAP LOOP 06/14/2013
K964594 CIRCON CORP. VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) 08/15/1997
K971838 COOPERSURGICAL, INC. MICRO ELECTRODES 11/05/1997
K964441 GYNECARE INNOVATION CENTER FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU 03/28/1997
K193516 Gynesonics, Inc Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 05/04/2020
K173703 Gynesonics, Inc. Sonata Sonography-Guided Transcervical Fibroid Ablation System 08/15/2018
K211535 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2 06/17/2021
K222304 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2 11/08/2022
K010425 HDC CORP. EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) 03/15/2001
K003405 HIGHLAND / MARIETTA, INC. ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO 05/07/2001
K022979 INSTRUMENTS MEDICAUX G.B., INC. LAPARETTE, MODEL LAP J L S H N 12/18/2002
K103726 INTEGRA LIFESCIENCES CORPORATION JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS 02/08/2012
K132135 LINA MEDICAL APS LINA GOLD LOOP HC 01/31/2014
K070315 LINA MEDICAL APS LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 10/30/2007
K092897 MEDSYS, S.A. LAP LOOP 02/01/2010
K981464 OMNITECH SYSTEMS, INC. OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE 07/10/1998
K981463 OMNITECH SYSTEMS, INC. OMNITECH RESECTOSCOPE ROLLER ELECTRODE 07/17/1998
K971146 RD CHUS, INC. LAPARETTE 08/25/1997
K970961 RICHARD WOLF MEDICAL INSTRUMENTS CORP. VAPORIZATION ELECTRODES 04/10/1998
K972856 ROCKET MEDICAL PLC ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS 02/11/1998


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