K181124 is an FDA 510(k) clearance for the Acessa ProVu System, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Acessa Health, Inc. (Austin, US). The FDA issued a Cleared decision on September 28, 2018, 151 days after receiving the submission on April 30, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K181124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2018 |
| Decision Date | September 28, 2018 |
| Days to Decision | 151 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 |