← Product Code [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI) · K961460

# LWEET CONE BIOPSY INSTRUMENT (K961460)

_Apple Medical Corp. · HGI · Nov 19, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K961460

## Device Facts

- **Applicant:** Apple Medical Corp.
- **Product Code:** [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI.md)
- **Decision Date:** Nov 19, 1996
- **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/K961460](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K961460)

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