Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

FDA product code KNF · 44 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4160
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-12-13 – 2026-09-24

KNF 2026-09-24

KARL STORZ SUPRALOOP

Applicant Karl Storz SE & CO. KG

K number K254303

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KNF 2025-04-02

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K number K250705

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KNF 2024-07-17

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K number K240503

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KNF 2023-12-21

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

Applicant Gynesonics, Inc.

K number K233848

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KNF 2022-11-08

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K number K222304

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KNF 2021-06-17

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K number K211535

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KNF 2020-05-04

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Applicant Gynesonics, Inc.

K number K193516

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KNF 2018-08-15

Sonata Sonography-Guided Transcervical Fibroid Ablation System

Applicant Gynesonics, Inc.

K number K173703

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KNF 2013-06-14

MODULAP LOOP

Applicant Atc Technologies, Inc.

K number K121343

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KNF 2012-02-08

JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS

Applicant Integra LifeSciences Corporation

K number K103726

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KNF 2010-02-01

LAP LOOP

Applicant Medsys, S.A.

K number K092897

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KNF 2007-10-30

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

Applicant Lina Medical Aps

K number K070315

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KNF 2002-12-18

LAPARETTE, MODEL LAP J L S H N

Applicant Instruments Medicaux G.B., Inc.

K number K022979

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KNF 2001-06-11

AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY

Applicant Aesculap, Inc.

K number K010752

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KNF 2001-05-07

ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO

Applicant Highland / Marietta, Inc.

K number K003405

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KNF 2001-03-15

EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

Applicant Hdc Corp.

K number K010425

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KNF 1998-07-17

OMNITECH RESECTOSCOPE ROLLER ELECTRODE

Applicant Omnitech Systems, Inc.

K number K981463

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KNF 1998-07-10

OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE

Applicant Omnitech Systems, Inc.

K number K981464

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KNF 1998-04-10

VAPORIZATION ELECTRODES

Applicant Richard Wolf Medical Instruments Corp.

K number K970961

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KNF 1998-02-11

ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS

Applicant Rocket Medical Plc

K number K972856

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KNF 1997-11-05

MICRO ELECTRODES

Applicant CooperSurgical, Inc.

K number K971838

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KNF 1997-08-25

LAPARETTE

Applicant Rd Chus, Inc.

K number K971146

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KNF 1997-08-15

VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)

Applicant Circon Corp.

K number K964594

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KNF 1997-06-20

RESISTICK SOLID LAPAROSCOPIC ELECTRODES

Applicant Aaron Medical Industries

K number K971621

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KNF 1997-03-28

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

Applicant Gynecare Innovation Center

K number K964441

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KNF 1995-10-06

SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES

Applicant Symbiosis Corp.

K number K953242

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KNF 1995-07-26

NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS

Applicant American Hydro-Surgical Instruments, Inc.

K number K952070

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KNF 1995-06-16

NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS

Applicant American Hydro-Surgical Instruments, Inc.

K number K950499

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KNF 1995-02-09

KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K944862

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KNF 1995-01-24

KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K944793

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KNF 1995-01-24

MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES

Applicant New Eder Corp.

K number K941207

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KNF 1994-12-15

KARL STORZ INSULATED BIOPSY FORCEPS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K944300

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KNF 1994-12-15

KARL STORZ INSULATED SCISSORS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K944297

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KNF 1994-09-30

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.

Applicant Lyle Howard Corp.

K number K933300

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KNF 1994-05-10

CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575

Applicant Viggo-Spectramed

K number K921727

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KNF 1994-04-21

JARIT SURGICAL INSTRUMENTS

Applicant J. Jamner Surgical Instruments, Inc.

K number K932456

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KNF 1994-03-30

ENDOMED LAPAROSCOPY INSTRUMENTS

Applicant Buckman Co., Inc.

K number K921686

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KNF 1994-02-28

HI-TOPS ELECTRODES 14-8000

Applicant W. J. Medical Instruments, Inc.

K number K935947

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KNF 1994-02-22

REFLEX(R) ESC

Applicant Richard-Allan Medical Ind., Inc.

K number K924200

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KNF 1990-09-19

GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES

Applicant Gynescope Corp.

K number K902658

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KNF 1987-07-10

ELECTRO-GYNE ELECTROSURGICAL GENERATOR

Applicant Cabot Medical Corp.

K number K871960

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KNF 1978-06-22

SCISSORS, HOOK, ELECTROSURGICAL

Applicant Kli

K number K780955

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KNF 1978-06-22

SCISSORS, HOOK, ELECTROSURGICAL

Applicant Kli

K number K780954

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KNF 1977-12-13

PROBE, COAGULATION ACCESSORY

Applicant Kli

K number K772220

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