Gynecologic electrocautery and accessories.

21 C.F.R. § 884.4120
in effectEffective: 2024-07-01
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(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).

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