K983840 is an FDA 510(k) clearance for the WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED). This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on May 20, 1999, 202 days after receiving the submission on October 30, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K983840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1998 |
| Decision Date | May 20, 1999 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGI — Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4120 |