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 |
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 |
K213135 |
Chirurgie Innovation |
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge |
03/02/2022 |
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 |
K210394 |
Dornier MedTech America Inc. |
Electrosurgical accessory |
05/19/2021 |
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 |
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 |
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 |
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 |
K210651 |
Olympus Winter & Ibe GmbH |
Resection Electrodes with HF cable |
08/03/2021 |
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 |
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 |
K974637 |
XIMED/PROSURE/INJECTX |
ELECTRODES/PROBES/DEVICES |
01/07/1998 |
K981256 |
XIMED/PROSURE/INJECTX |
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE |
05/12/1998 |