---
kind: "section"
citation: "21 C.F.R. § 884.4100"
title: "21"
number: "884.4100"
heading: "Endoscopic electrocautery and accessories."
url: "https://uscodex.org/cfr/21/884.4100"
---

# §884.4100. Endoscopic electrocautery and accessories.

- (a) **Identification.** An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is designed to coagulate fallopian tube tissue with a probe heated by low-voltage energy. This generic type of device may include the following accessories: electrical generators, probes, and electrical cables.
- (b) **Classification.** Class II. The special controls for this device are:
  - (1) **FDA's—**
    - (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
    - (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
    - (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
  - (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—[Part 1](/cfr/21/part1.md): General Requirements for Safety,”
  - (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
  - (4) **Labeling—**
    - (i) **Indication—** For female tubal sterilization, and
    - (ii) **Instructions for use—**
      - (A) Destroy at least 2 centimeters of the fallopian tubes,
      - (B) Use a cut or undampened sinusoidal waveform,
      - (C) Use a minimum power of 25 watts, and
      - (D) **For devices with ammeters—** continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.

## Notes

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]

### 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.

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]