WALLACH INTEGRATION UNIT
Device Facts
| Record ID | K963348 |
|---|---|
| Device Name | WALLACH INTEGRATION UNIT |
| Applicant | Wallach Surgical Devices, Inc. |
| Product Code | HGI · Obstetrics/Gynecology |
| Decision Date | Mar 19, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.
