HFG · Coagulator, Laparoscopic, Unipolar (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4160 · Class 2
Overview
| Product Code | HFG |
|---|---|
| Device Name | Coagulator, Laparoscopic, Unipolar (And Accessories) |
| Regulation | 21 CFR 884.4160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | Acessa ProVu System | Acessa Health, Inc. | Sep 28, 2018 | SESE |
| K132744 | ACESSA GUIDANCE SYSTEM | Halt Medical, Inc. | May 27, 2014 | SESE |
| K132184 | ACESSA GUIDANCE HANDPIECE | Halt Medical, Inc. | Apr 28, 2014 | SESE |
| K121858 | THE ABLATION SYSTEM | Halt Medical, Inc. | Nov 5, 2012 | SESE |
| K101606 | MICROMED PD-8K INSULATION DEFECT DETECTOR | Mcgan Technology, LLC | Oct 1, 2010 | SESE |
| K991424 | INSULSCAN INSULATION TESTING SYSTEM | Medicor Corp. | Jul 22, 1999 | SESE |
| K961695 | ENDO-TECH LTD., TIPS | Ratio Design Lab | Jul 1, 1996 | SESE |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Davol, Inc. | Mar 25, 1994 | SESE |
| K915406 | DAVOL ELECTROSUGICAL PROBES | Davol, Inc. | Feb 28, 1992 | SESE |
| K904240 | SINGLE USE LAPARSCOPIC ELECTRODE | Aspen Labs | Feb 19, 1991 | SESE |
| K902555 | AMCATH COAGULATION PROBE | Intl. Medical, Inc. | Jun 20, 1990 | SESE |
Top Applicants
- Halt Medical, Inc. — 3 clearances
- Davol, Inc. — 2 clearances
- Ratio Design Lab — 1 clearance
- Medicor Corp. — 1 clearance
- Mcgan Technology, LLC — 1 clearance
