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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 884Subpart E → §884.4120


Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart E—Obstetrical and Gynecological Surgical Devices


§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).

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