21 CFR 884.4120
§ 884.4120 Gynecologic electrocautery and accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.4120, § 884.4120 Gynecologic electrocautery and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90823
- Permanent ID
ys:prov:90823@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.