§ 884.4120. Gynecologic electrocautery and accessories.
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/us/cfr/t21/s§ 884.4120·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.
(b)Classification. Class II (performance standards).