KNF · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4160 · Class 2
Overview
| Product Code | KNF |
|---|---|
| Device Name | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) |
| Regulation | 21 CFR 884.4160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Apr 2, 2025 | SESE |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Jul 17, 2024 | SESE |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | Dec 21, 2023 | SESE |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Nov 8, 2022 | SESE |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | Jun 17, 2021 | SESE |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | May 4, 2020 | SESE |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | Aug 15, 2018 | SESE |
| K132135 | LINA GOLD LOOP HC | Lina Medical Aps | Jan 31, 2014 | SESE |
| K121343 | MODULAP LOOP | Atc Technologies, Inc. | Jun 14, 2013 | SESE |
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | Feb 8, 2012 | SESE |
| K092897 | LAP LOOP | Medsys, S.A. | Feb 1, 2010 | SESE |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | Oct 30, 2007 | SESE |
| K022979 | LAPARETTE, MODEL LAP J L S H N | Instruments Medicaux G.B., Inc. | Dec 18, 2002 | SESE |
| K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | Jun 11, 2001 | SESE |
| K003405 | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO | Highland / Marietta, Inc. | May 7, 2001 | SESE |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Hdc Corp. | Mar 15, 2001 | SESE |
| K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | Jul 17, 1998 | SESE |
| K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | Jul 10, 1998 | SESE |
| K970961 | VAPORIZATION ELECTRODES | Richard Wolf Medical Instruments Corp. | Apr 10, 1998 | SESE |
| K972856 | 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
- Omnitech Systems, Inc. — 2 clearances
- Lina Medical Aps — 2 clearances
