← Product Code [HFI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI) · K925114

# LAPAROSCOPIC INSTRUMENTS (K925114)

_Endo Technic Corp. · HFI · Feb 28, 1994 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K925114

## Device Facts

- **Applicant:** Endo Technic Corp.
- **Product Code:** [HFI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI.md)
- **Decision Date:** Feb 28, 1994
- **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/HFI/K925114](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K925114)

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