K121858 is an FDA 510(k) clearance for the THE ABLATION SYSTEM, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Halt Medical, Inc. (Brentwood, US). The FDA issued a Cleared decision on November 5, 2012, 132 days after receiving the submission on June 26, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K121858 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2012 |
| Decision Date | November 05, 2012 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFG — Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |