---
kind: "section"
citation: "21 C.F.R. § 884.4160"
title: "21"
number: "884.4160"
heading: "Unipolar endoscopic coagulator-cutter and accessories."
url: "https://uscodex.org/cfr/21/884.4160"
---

# §884.4160. Unipolar endoscopic coagulator-cutter and accessories.

- (a) **Identification.** A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.