K132744 is an FDA 510(k) clearance for the ACESSA GUIDANCE 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 May 27, 2014, 266 days after receiving the submission on September 3, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K132744 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2013 |
| Decision Date | May 27, 2014 |
| Days to Decision | 266 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 |