Product Code: KNF FDA class 2 21 CFR 884.4160

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Obstetrics/Gynecology

An Endoscopic Unipolar Coagulator-Cutter with Accessories is an electrosurgical device used in gynecologic laparoscopy to cut and coagulate tissue using high-frequency electrical current through a single active electrode, applied in procedures such as tubal ligation and laparoscopic surgery. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNF and it is regulated under 21 CFR 884.4160 in the Obstetrics and Gynecology specialty. This device is eligible for third-party review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: KNF
Device Class: FDA class 2
Regulation Number: 884.4160
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250705	Sonata Transcervical Fibroid Ablation System 2.2	Apr 02, 2025	Substantially Equivalent	Gynesonics, Inc.
K240503	Sonata Transcervical Fibroid Ablation System 2.2	Jul 17, 2024	Substantially Equivalent	Gynesonics, Inc.
K233848	Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)	Dec 21, 2023	Substantially Equivalent	Gynesonics, Inc.
K222304	Sonata Transcervical Fibroid Ablation System 2.2	Nov 08, 2022	Substantially Equivalent	Gynesonics, Inc.
K211535	Sonata Transcervical Fibroid Ablation System 2.2	Jun 17, 2021	Substantially Equivalent	Gynesonics, Inc.
K193516	Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1	May 04, 2020	Substantially Equivalent	Gynesonics, Inc.
K173703	Sonata Sonography-Guided Transcervical Fibroid Ablation System	Aug 15, 2018	Substantially Equivalent	Gynesonics, Inc.
K132135	LINA GOLD LOOP HC	Jan 31, 2014	Substantially Equivalent	Lina Medical Aps
K121343	MODULAP LOOP	Jun 14, 2013	Substantially Equivalent	Atc Technologies, Inc.
K103726	JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS	Feb 08, 2012	Substantially Equivalent	Integra LifeSciences Corporation
K092897	LAP LOOP	Feb 01, 2010	Substantially Equivalent	Medsys, S.A.
K070315	LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8	Oct 30, 2007	Substantially Equivalent	Lina Medical Aps
K022979	LAPARETTE, MODEL LAP J L S H N	Dec 18, 2002	Substantially Equivalent	Instruments Medicaux G.B., Inc.
K010752	AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY	Jun 11, 2001	Substantially Equivalent	Aesculap, Inc.
K003405	ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO	May 07, 2001	Substantially Equivalent	Highland / Marietta, Inc.
K010425	EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)	Mar 15, 2001	Substantially Equivalent	Hdc Corp.
K981463	OMNITECH RESECTOSCOPE ROLLER ELECTRODE	Jul 17, 1998	Substantially Equivalent	Omnitech Systems, Inc.
K981464	OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE	Jul 10, 1998	Substantially Equivalent	Omnitech Systems, Inc.
K970961	VAPORIZATION ELECTRODES	Apr 10, 1998	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K972856	ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS	Feb 11, 1998	Substantially Equivalent	Rocket Medical Plc
K971838	MICRO ELECTRODES	Nov 05, 1997	Substantially Equivalent	CooperSurgical, Inc.
K971146	LAPARETTE	Aug 25, 1997	Substantially Equivalent	Rd Chus, Inc.
K964594	VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)	Aug 15, 1997	Substantially Equivalent	Circon Corp.
K971621	RESISTICK SOLID LAPAROSCOPIC ELECTRODES	Jun 20, 1997	Substantially Equivalent	Aaron Medical Industries
K964441	FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU	Mar 28, 1997	Substantially Equivalent	Gynecare Innovation Center
K953242	SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES	Oct 06, 1995	Substantially Equivalent	Symbiosis Corp.
K952070	NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS	Jul 26, 1995	Substantially Equivalent	American Hydro-Surgical Instruments, Inc.
K950499	NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS	Jun 16, 1995	Substantially Equivalent	American Hydro-Surgical Instruments, Inc.
K944862	KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES	Feb 09, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944793	KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES	Jan 24, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K941207	MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES	Jan 24, 1995	Substantially Equivalent	New Eder Corp.
K944300	KARL STORZ INSULATED BIOPSY FORCEPS	Dec 15, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944297	KARL STORZ INSULATED SCISSORS	Dec 15, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K933300	GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.	Sep 30, 1994	Substantially Equivalent	Lyle Howard Corp.
K921727	CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575	May 10, 1994	Substantially Equivalent	Viggo-Spectramed
K932456	JARIT SURGICAL INSTRUMENTS	Apr 21, 1994	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K921686	ENDOMED LAPAROSCOPY INSTRUMENTS	Mar 30, 1994	Substantially Equivalent	Buckman Co., Inc.
K935947	HI-TOPS ELECTRODES 14-8000	Feb 28, 1994	Substantially Equivalent	W. J. Medical Instruments, Inc.
K924200	REFLEX(R) ESC	Feb 22, 1994	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K902658	GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES	Sep 19, 1990	Substantially Equivalent	Gynescope Corp.
K871960	ELECTRO-GYNE ELECTROSURGICAL GENERATOR	Jul 10, 1987	Substantially Equivalent	Cabot Medical Corp.
K780955	SCISSORS, HOOK, ELECTROSURGICAL	Jun 22, 1978	Substantially Equivalent	Kli
K780954	SCISSORS, HOOK, ELECTROSURGICAL	Jun 22, 1978	Substantially Equivalent	Kli
K772220	PROBE, COAGULATION ACCESSORY	Dec 13, 1977	Substantially Equivalent	Kli