K152843 is an FDA 510(k) clearance for the Liger Medical HTU-110. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Liger Medical, LLC (Draper, US). The FDA issued a Cleared decision on June 24, 2016, 269 days after receiving the submission on September 29, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K152843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2015 |
| Decision Date | June 24, 2016 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGI - Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4120 |