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) → HFG — Coagulator, Laparoscopic, Unipolar (And Accessories)

# HFG · Coagulator, Laparoscopic, Unipolar (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/HFG

## Overview

- **Product Code:** HFG
- **Device Name:** Coagulator, Laparoscopic, Unipolar (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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K181124](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K181124.md) | Acessa ProVu System | Acessa Health, Inc. | Sep 28, 2018 | SESE |
| [K132744](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K132744.md) | ACESSA GUIDANCE SYSTEM | Halt Medical, Inc. | May 27, 2014 | SESE |
| [K132184](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K132184.md) | ACESSA GUIDANCE HANDPIECE | Halt Medical, Inc. | Apr 28, 2014 | SESE |
| [K121858](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K121858.md) | THE ABLATION SYSTEM | Halt Medical, Inc. | Nov 5, 2012 | SESE |
| [K101606](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K101606.md) | MICROMED PD-8K INSULATION DEFECT DETECTOR | Mcgan Technology, LLC | Oct 1, 2010 | SESE |
| [K991424](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K991424.md) | INSULSCAN INSULATION TESTING SYSTEM | Medicor Corp. | Jul 22, 1999 | SESE |
| [K961695](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K961695.md) | ENDO-TECH LTD., TIPS | Ratio Design Lab | Jul 1, 1996 | SESE |
| [K921405](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K921405.md) | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Davol, Inc. | Mar 25, 1994 | SESE |
| [K915406](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K915406.md) | DAVOL ELECTROSUGICAL PROBES | Davol, Inc. | Feb 28, 1992 | SESE |
| [K904240](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K904240.md) | SINGLE USE LAPARSCOPIC ELECTRODE | Aspen Labs | Feb 19, 1991 | SESE |
| [K902555](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFG/K902555.md) | AMCATH COAGULATION PROBE | Intl. Medical, Inc. | Jun 20, 1990 | SESE |

## Top Applicants

- Halt Medical, Inc. — 3 clearances
- Davol, Inc. — 2 clearances
- Acessa Health, Inc. — 1 clearance
- Aspen Labs — 1 clearance
- Intl. Medical, Inc. — 1 clearance

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

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