← Product Code [HFG](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG) · K902555

# AMCATH COAGULATION PROBE (K902555)

_Intl. Medical, Inc. · HFG · Jun 20, 1990 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K902555

## Device Facts

- **Applicant:** Intl. Medical, Inc.
- **Product Code:** [HFG](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG.md)
- **Decision Date:** Jun 20, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4160
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K902555](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K902555)

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