HIN · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4150 · Class 2
Overview
| Product Code | HIN |
|---|---|
| Device Name | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) |
| Regulation | 21 CFR 884.4150 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | PK Lap Loop | Olympus Winter & Ibe GmbH | Nov 21, 2014 | SESE |
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | Lina Medical Aps | Jul 24, 2013 | SESE |
| K122983 | KSEA BIPOLAR ELECTRODE | KARL STORZ Endoscopy-America, Inc. | Jun 26, 2013 | SESE |
| K122605 | PKS BILL | Gyrus Acmi, Inc. | Dec 5, 2012 | SESE |
| K113080 | TUBALGATOR | Mectra Labs, Inc. | Jun 29, 2012 | SESE |
| K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | ETHICON, Inc. | Dec 2, 2011 | SESE |
| K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) | Gyrus Acmi, Inc. | Sep 1, 2011 | SESE |
| K990147 | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | Richard Wolf Medical Instruments Corp. | Apr 16, 1999 | SESE |
| K971565 | BICOAG COAGULATING FORCEPS | Everest Medical Corp. | Mar 12, 1998 | SESE |
| K926517 | ELMED LBC 50-P | Elmed, Inc. | Nov 15, 1994 | SESE |
| K943776 | COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | Nov 3, 1994 | SESE |
| K911699 | STI TISSUE MANIPULATOR | Surgical Technologies, Inc. | Jun 13, 1991 | SESE |
| K871745 | MODEL 26021C BIPOLAR COAGULATOR | KARL STORZ Endoscopy-America, Inc. | Jul 10, 1987 | SESE |
| K790043 | TRACOR, CANNULA, BICEPTS BIPOLAR | Neomed Corp. | Feb 8, 1979 | SESE |
| K781109 | FORCEPS, ELECTROSURGICAL | Kli | Sep 14, 1978 | SESE |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | Kli | Jul 17, 1978 | SESE |
Top Applicants
- Richard Wolf Medical Instruments Corp. — 2 clearances
- Kli — 2 clearances
- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Gyrus Acmi, Inc. — 2 clearances
- Surgical Technologies, Inc. — 1 clearance
