21 CFR § 884.4120 Obstetrical and Gynecological Devices

§ 884.4120 Gynecologic electrocautery and accessories.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.4100 Endoscopic electrocautery and accessories.§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories. →