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Code of Federal Regulations Title 21. Food and Drugs § 21.884.4150 Bipolar endoscopic coagulator-cutter and accessories

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) 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.

(b) 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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.884.4150 Bipolar endoscopic coagulator-cutter and accessories - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-884-4150/

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