FDA 510(k) Applications for Medical Device Product Code "FAS"
(Electrode, Electrosurgical, Active, Urological)

FDA 510(k) Number Applicant Device Name Decision Date
K031001 ACMI CORPORATION ACMI VISTA CTR BIPOLAR LOOP ELECTRODE 05/21/2003
K971512 AMERICAN MEDICAL SYSTEMS, INC. AMS COAGULOOP RESECTION ELECTRODE 07/24/1997
K991314 AMERICAN MEDICAL SYSTEMS, INC. COAGULOOP 06/29/1999
K943879 AMERICAN UROLOGICALS, INC. RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP 02/07/1995
K905731 APPLIED UROLOGY, INC. FLEXIBLE ENDOSCOPIC ELECTRODE 01/31/1991
K915219 APPLIED UROLOGY, INC. URETHRAL ELECTRODE SHEATH 07/23/1992
K022543 ARTHROCARE CORP. ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM 08/30/2002
K031029 ARTHROCARE CORP. ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM 06/19/2003
K955531 ARTHROCARE CORP. ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM 02/21/1996
K970526 ARTHROCARE CORP. ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP 05/28/1997
K961069 ARTHROCARE CORP. ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM 05/28/1996
K962538 C.R. BARD, INC. BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) 12/17/1996
K961841 C.R. BARD, INC. BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) 10/09/1996
K163090 Chirurgie Innovation Plasma Edge System 05/23/2017
K973820 CIRCON CORP. USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE 05/12/1998
K965118 ENDOCARE, INC. ENDOCARE MONOPOLAR ELECTRODE 02/25/1997
K974516 ENDOLAP, INC. ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE 12/22/1997
K974515 ENDOLAP, INC. ENDOLAP RESECTOSCOPE ROLLER ELECTRODE 12/22/1997
K933175 GREENWALD SURGICAL CO., INC. GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE 04/01/1994
K933173 GREENWALD SURGICAL CO., INC. GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE 04/01/1994
K933174 GREENWALD SURGICAL CO., INC. GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE 04/01/1994
K093181 GYRUS ACMI, INC. GYRUS ACMI PK BUTTON ELECTRODE 02/24/2010
K120567 GYRUS ACMI, INC. GYRUS AMCI PK BUTTON ELECTRODE 06/20/2012
K961702 KARL STORZ ENDOSKOP GMBH KSEA VAPORIZATION ELECTRODES 08/29/1996
K061541 KSEA KSEA BIPOLAR ELECTROTOME 08/21/2006
K962653 MICROGYN CORP. MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT 02/04/1997
K091511 MODERN MEDICAL EQUIPMENT MFG., LTD. MODERN MEDICAL RESECTOSCOPE ELECTRODES 01/15/2010
K903156 NORTH AMERICAN STERILIZATION & PACKAGING CO. CONTROL-TIP CYSTOSCOPIC ELECTRODES 12/18/1990
K903162 NORTH AMERICAN STERILIZATION & PACKAGING CO. FLEXIBLE ENDOSCOPIC ELECTRODES 12/18/1990
K954710 NORTHGATE TECHNOLOGIES, INC. VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. 04/24/1996
K970717 NORTHGATE TECHNOLOGIES, INC. VAPOR-TECH SLED ELECTRODE 05/08/1997
K951863 OLYMPUS AMERICA, INC. ROLLER ELECTRODE 08/24/1995
K931763 OLYMPUS CORP. HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS 08/29/1994
K120418 OLYMPUS WINTER & IBE GMBH ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES 06/20/2012
K102781 OLYMPUS WINTER & IBE GMBH RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS 01/11/2011
K152092 Olympus Winter & Ibe GmbH Resection Electrodes 10/26/2015
K171965 Olympus Winter & Ibe GmbH Resection Electrodes with HF cable 09/28/2017
K100275 OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS 07/01/2010
K050454 OMNITECH SYSTEMS, INC. OMNITECH FULGURATING ELECTRODE 05/27/2005
K151976 OMNITECH SYSTEMS, INC. Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode 06/27/2016
K965093 OMNITECH SYSTEMS, INC. OMNITECH RESECTOSCOPE ROLLER ELECTRODE 03/19/1997
K964365 OMNITECH SYSTEMS, INC. RESECTOSCOPE CUTTING LOOP ELECTRODE 04/22/1997
K951897 POWER ANALYTICS CORP. POWER RESECTOSCOPE CUTTING LOOP 07/18/1995
K050488 PROSURG, INC. TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES 04/01/2005
K953983 RICHARD WOLF MEDICAL INSTRUMENTS CORP. EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE 10/02/1996
K053322 ROEI MEDICAL TECHNOLOGIES, LTD. MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS 01/06/2006
K050910 ROEI MEDICAL TECHNOLOGIES, LTD. ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS 06/16/2005
K953453 SYMBIOSIS CORP. SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES 01/17/1996
K945191 UN-I-MED, INC. ENDOSCOPIC ACCESSORY 05/03/1995
K974637 XIMED/PROSURE/INJECTX ELECTRODES/PROBES/DEVICES 01/07/1998
K981256 XIMED/PROSURE/INJECTX ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE 05/12/1998


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