← Product Code [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI) · K003608

# SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (K003608)

_Aesculap, Inc. · HGI · Feb 20, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K003608

## Device Facts

- **Applicant:** Aesculap, Inc.
- **Product Code:** [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI.md)
- **Decision Date:** Feb 20, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4120
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K003608](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K003608)

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