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 884.4160](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4160) → HFH — Coagulator, Hysteroscopic (And Accessories)

# HFH · Coagulator, Hysteroscopic (And Accessories)

_Obstetrics/Gynecology · 21 CFR 884.4160 · Class 2_

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

## Overview

- **Product Code:** HFH
- **Device Name:** Coagulator, Hysteroscopic (And Accessories)
- **Regulation:** [21 CFR 884.4160](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4160)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

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

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