K130305 is an FDA 510(k) clearance for the LINA BIPOLAR LOOP. This device is classified as a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II - Special Controls, product code HIN).
Submitted by Lina Medical Aps (Austin, US). The FDA issued a Cleared decision on July 24, 2013, 169 days after receiving the submission on February 5, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4150.
| 510(k) Number | K130305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2013 |
| Decision Date | July 24, 2013 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIN - Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4150 |