Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4100](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4100) → HIM — Electrocautery, Endoscopic And Accessories

# HIM · Electrocautery, Endoscopic And Accessories

_Obstetrics/Gynecology · 21 CFR 884.4100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIM

## Overview

- **Product Code:** HIM
- **Device Name:** Electrocautery, Endoscopic And Accessories
- **Regulation:** [21 CFR 884.4100](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4100)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

Class II. The special controls for this device are:

## Special Controls

*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: 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIM](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HIM)

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