21 CFR 884.4120 — Electrocautery, Gynecologic (And Accessories)

Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4120

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HGIElectrocautery, Gynecologic (And Accessories)2533rd Party
Innolitics

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