K130606 is an FDA 510(k) clearance for the FMWAND FERROMAGNETIC SURGICAL SYSTEM. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Domain Surgical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 3, 2014, 302 days after receiving the submission on March 7, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K130606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2013 |
| Decision Date | January 03, 2014 |
| Days to Decision | 302 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 |