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) → HFI — Coagulator, Culdoscopic (And Accessories)

# HFI · Coagulator, Culdoscopic (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/HFI

## Overview

- **Product Code:** HFI
- **Device Name:** Coagulator, Culdoscopic (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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151567](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K151567.md) | ENDOPLUS hand-held laparoscopic instruments | Endoplus | Dec 23, 2015 | SESE |
| [K925960](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K925960.md) | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | Jun 7, 1994 | SESE |
| [K925957](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K925957.md) | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | Jun 7, 1994 | SESE |
| [K936026](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K936026.md) | COOK LAPAROSCOPIC MINI RETRACTOR SET | Cook Urological, Inc. | Mar 11, 1994 | SESE |
| [K925114](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K925114.md) | LAPAROSCOPIC INSTRUMENTS | Endo Technic Corp. | Feb 28, 1994 | SESE |
| [K924148](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K924148.md) | DIAMOND-SHARP(R) TROCARS | Snowden-Pencer | Feb 28, 1994 | SESE |
| [K930571](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K930571.md) | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | Numed Technologies, Inc. | Feb 1, 1994 | SESE |
| [K844053](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HFI/K844053.md) | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Canon USA, Inc. | Dec 19, 1984 | SESE |

## Top Applicants

- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Canon USA, Inc. — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Endo Technic Corp. — 1 clearance
- Endoplus — 1 clearance

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

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