Title 21: Food and Drugs
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/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart E - Obstetrical and Gynecological Surgical Devices / § 884.4120 Gynecologic electrocautery and accessories.
§ 884.4120 Gynecologic electrocautery and accessories.
(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).