SINGLE USE LAPARSCOPIC ELECTRODE
Device Facts
| Record ID | K904240 |
|---|---|
| Device Name | SINGLE USE LAPARSCOPIC ELECTRODE |
| Applicant | Aspen Labs |
| Product Code | HFG · Obstetrics/Gynecology |
| Decision Date | Feb 19, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4160 |
| Device Class | Class 2 |
Regulatory Classification
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.
