Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4160](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4160) → KNF — Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) # KNF · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) _Obstetrics/Gynecology · 21 CFR 884.4160 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF ## Overview - **Product Code:** KNF - **Device Name:** Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) - **Regulation:** [21 CFR 884.4160](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4160) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 44) Showing 20 most recent of 44 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250705](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K250705.md) | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Apr 2, 2025 | SESE | | [K240503](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K240503.md) | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Jul 17, 2024 | SESE | | [K233848](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K233848.md) | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | Dec 21, 2023 | SESE | | [K222304](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K222304.md) | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Nov 8, 2022 | SESE | | [K211535](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K211535.md) | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Jun 17, 2021 | SESE | | [K193516](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K193516.md) | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | May 4, 2020 | SESE | | [K173703](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K173703.md) | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | Aug 15, 2018 | SESE | | [K132135](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K132135.md) | LINA GOLD LOOP HC | Lina Medical Aps | Jan 31, 2014 | SESE | | [K121343](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K121343.md) | MODULAP LOOP | Atc Technologies, Inc. | Jun 14, 2013 | SESE | | [K103726](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K103726.md) | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | Feb 8, 2012 | SESE | | [K092897](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K092897.md) | LAP LOOP | Medsys, S.A. | Feb 1, 2010 | SESE | | [K070315](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K070315.md) | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | Oct 30, 2007 | SESE | | [K022979](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K022979.md) | LAPARETTE, MODEL LAP J L S H N | Instruments Medicaux G.B., Inc. | Dec 18, 2002 | SESE | | [K010752](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K010752.md) | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | Jun 11, 2001 | SESE | | [K003405](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K003405.md) | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO | Highland / Marietta, Inc. | May 7, 2001 | SESE | | [K010425](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K010425.md) | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Hdc Corp. | Mar 15, 2001 | SESE | | [K981463](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K981463.md) | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | Jul 17, 1998 | SESE | | [K981464](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K981464.md) | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | Jul 10, 1998 | SESE | | [K970961](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K970961.md) | VAPORIZATION ELECTRODES | Richard Wolf Medical Instruments Corp. | Apr 10, 1998 | SESE | | [K972856](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF/K972856.md) | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS | Rocket Medical Plc | Feb 11, 1998 | SESE | ## Top Applicants - Gynesonics, Inc. — 7 clearances - KARL STORZ Endoscopy-America, Inc. — 4 clearances - Kli — 3 clearances - American Hydro-Surgical Instruments, Inc. — 2 clearances - Lina Medical Aps — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KNF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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