Electrode, Electrosurgical, Active, Urological

FDA product code FAS · 57 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.4300
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1990-12-18 – 2025-12-05

FAS 2025-12-05

Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )

Applicant Dornier Medtech America Inc (Dmta)

K number K251403

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FAS 2025-06-27

Multi4 System

Applicant Multi4 Medical AB

K number K250522

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FAS 2024-06-12

PLASMA EDGE System

Applicant Lamidey Noury Medical

K number K240504

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FAS 2022-03-02

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Applicant Chirurgie Innovation

K number K213135

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FAS 2021-08-03

Resection Electrodes with HF cable

Applicant Olympus Winter & Ibe GmbH

K number K210651

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FAS 2021-05-19

Electrosurgical accessory

Applicant Dornier Medtech America, Inc.

K number K210394

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FAS 2017-09-28

Resection Electrodes with HF cable

Applicant Olympus Winter & Ibe GmbH

K number K171965

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FAS 2017-05-23

Plasma Edge System

Applicant Chirurgie Innovation

K number K163090

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FAS 2016-06-27

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

Applicant Omnitech Systems, Inc.

K number K151976

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FAS 2012-06-20

GYRUS AMCI PK BUTTON ELECTRODE

Applicant Gyrus Acmi, Inc.

K number K120567

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FAS 2012-06-20

ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Applicant Olympus Winter & Ibe GmbH

K number K120418

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FAS 2011-01-11

RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS

Applicant Olympus Winter & Ibe GmbH

K number K102781

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FAS 2010-07-01

WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS

Applicant Olympus Winter & Ibe GmbH

K number K100275

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FAS 2010-02-24

GYRUS ACMI PK BUTTON ELECTRODE

Applicant Gyrus Acmi, Inc.

K number K093181

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FAS 2010-01-15

MODERN MEDICAL RESECTOSCOPE ELECTRODES

Applicant Modern Medical Equipment Mfg., Ltd.

K number K091511

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FAS 2006-08-21

KSEA BIPOLAR ELECTROTOME

Applicant Ksea

K number K061541

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FAS 2006-01-06

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

Applicant Roei Medical Technologies, Ltd.

K number K053322

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FAS 2005-06-16

ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS

Applicant Roei Medical Technologies, Ltd.

K number K050910

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FAS 2005-05-27

OMNITECH FULGURATING ELECTRODE

Applicant Omnitech Systems, Inc.

K number K050454

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FAS 2005-04-01

TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES

Applicant Prosurg, Inc.

K number K050488

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FAS 2003-06-19

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM

Applicant Arthrocare Corp.

K number K031029

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FAS 2003-05-21

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE

Applicant Acmi Corporation

K number K031001

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FAS 2002-08-30

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM

Applicant Arthrocare Corp.

K number K022543

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FAS 1999-06-29

COAGULOOP

Applicant American Medical Systems, Inc.

K number K991314

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FAS 1998-05-12

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

Applicant Ximed/Prosure/Injectx

K number K981256

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FAS 1998-05-12

USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE

Applicant Circon Corp.

K number K973820

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FAS 1998-01-07

ELECTRODES/PROBES/DEVICES

Applicant Ximed/Prosure/Injectx

K number K974637

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FAS 1997-12-22

ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE

Applicant Endolap, Inc.

K number K974516

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FAS 1997-12-22

ENDOLAP RESECTOSCOPE ROLLER ELECTRODE

Applicant Endolap, Inc.

K number K974515

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FAS 1997-07-24

AMS COAGULOOP RESECTION ELECTRODE

Applicant American Medical Systems, Inc.

K number K971512

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FAS 1997-05-28

ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP

Applicant Arthrocare Corp.

K number K970526

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FAS 1997-05-08

VAPOR-TECH SLED ELECTRODE

Applicant Northgate Technologies, Inc.

K number K970717

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FAS 1997-04-22

RESECTOSCOPE CUTTING LOOP ELECTRODE

Applicant Omnitech Systems, Inc.

K number K964365

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FAS 1997-03-19

OMNITECH RESECTOSCOPE ROLLER ELECTRODE

Applicant Omnitech Systems, Inc.

K number K965093

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FAS 1997-02-25

ENDOCARE MONOPOLAR ELECTRODE

Applicant Endocare, Inc.

K number K965118

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FAS 1997-02-04

MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT

Applicant Microgyn Corp.

K number K962653

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FAS 1996-12-17

BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)

Applicant C.R. Bard, Inc.

K number K962538

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FAS 1996-10-09

BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)

Applicant C.R. Bard, Inc.

K number K961841

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FAS 1996-10-02

EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE

Applicant Richard Wolf Medical Instruments Corp.

K number K953983

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FAS 1996-08-29

KSEA VAPORIZATION ELECTRODES

Applicant Karl Storz Endoskop GmbH

K number K961702

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FAS 1996-05-28

ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM

Applicant Arthrocare Corp.

K number K961069

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FAS 1996-04-24

VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.

Applicant Northgate Technologies, Inc.

K number K954710

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FAS 1996-02-21

ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM

Applicant Arthrocare Corp.

K number K955531

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FAS 1996-01-17

SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES

Applicant Symbiosis Corp.

K number K953453

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FAS 1995-08-24

ROLLER ELECTRODE

Applicant Olympus America, Inc.

K number K951863

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FAS 1995-07-18

POWER RESECTOSCOPE CUTTING LOOP

Applicant Power Analytics Corp.

K number K951897

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FAS 1995-05-03

ENDOSCOPIC ACCESSORY

Applicant Un-I-Med, Inc.

K number K945191

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FAS 1995-02-07

RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP

Applicant American Urologicals, Inc.

K number K943879

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FAS 1994-12-21

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K944795

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FAS 1994-08-29

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS

Applicant Olympus Corp.

K number K931763

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FAS 1994-04-01

GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE

Applicant Greenwald Surgical Co., Inc.

K number K933175

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FAS 1994-04-01

GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE

Applicant Greenwald Surgical Co., Inc.

K number K933174

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FAS 1994-04-01

GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE

Applicant Greenwald Surgical Co., Inc.

K number K933173

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FAS 1992-07-23

URETHRAL ELECTRODE SHEATH

Applicant Applied Urology, Inc.

K number K915219

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FAS 1991-01-31

FLEXIBLE ENDOSCOPIC ELECTRODE

Applicant Applied Urology, Inc.

K number K905731

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FAS 1990-12-18

FLEXIBLE ENDOSCOPIC ELECTRODES

Applicant North American Sterilization & Packaging Co.

K number K903162

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FAS 1990-12-18

CONTROL-TIP CYSTOSCOPIC ELECTRODES

Applicant North American Sterilization & Packaging Co.

K number K903156

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