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 884.4150](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4150) → HIN — Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) # HIN · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) _Obstetrics/Gynecology · 21 CFR 884.4150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN ## Overview - **Product Code:** HIN - **Device Name:** Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) - **Regulation:** [21 CFR 884.4150](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4150) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables. ## Classification Rationale Class II. The special controls for this device are: ## Special Controls *Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction. ## Recent Cleared Devices (16 of 16) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K142525](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K142525.md) | PK Lap Loop | Olympus Winter & Ibe GmbH | Nov 21, 2014 | SESE | | [K130305](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K130305.md) | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | Lina Medical Aps | Jul 24, 2013 | SESE | | [K122983](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K122983.md) | KSEA BIPOLAR ELECTRODE | KARL STORZ Endoscopy-America, Inc. | Jun 26, 2013 | SESE | | [K122605](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K122605.md) | PKS BILL | Gyrus Acmi, Inc. | Dec 5, 2012 | SESE | | [K113080](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K113080.md) | TUBALGATOR | Mectra Labs, Inc. | Jun 29, 2012 | SESE | | [K111751](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K111751.md) | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | ETHICON, Inc. | Dec 2, 2011 | SESE | | [K111059](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K111059.md) | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Gyrus Acmi, Inc. | Sep 1, 2011 | SESE | | [K990147](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K990147.md) | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | Richard Wolf Medical Instruments Corp. | Apr 16, 1999 | SESE | | [K971565](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K971565.md) | BICOAG COAGULATING FORCEPS | Everest Medical Corp. | Mar 12, 1998 | SESE | | [K926517](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K926517.md) | ELMED LBC 50-P | Elmed, Inc. | Nov 15, 1994 | SESE | | [K943776](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K943776.md) | COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | Nov 3, 1994 | SESE | | [K911699](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K911699.md) | STI TISSUE MANIPULATOR | Surgical Technologies, Inc. | Jun 13, 1991 | SESE | | [K871745](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K871745.md) | MODEL 26021C BIPOLAR COAGULATOR | KARL STORZ Endoscopy-America, Inc. | Jul 10, 1987 | SESE | | [K790043](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K790043.md) | TRACOR, CANNULA, BICEPTS BIPOLAR | Neomed Corp. | Feb 8, 1979 | SESE | | [K781109](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K781109.md) | FORCEPS, ELECTROSURGICAL | Kli | Sep 14, 1978 | SESE | | [K781089](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN/K781089.md) | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Kli | Jul 17, 1978 | SESE | ## Top Applicants - Gyrus Acmi, Inc. — 2 clearances - KARL STORZ Endoscopy-America, Inc. — 2 clearances - Kli — 2 clearances - Richard Wolf Medical Instruments Corp. — 2 clearances - ETHICON, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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