K111059 is an FDA 510(k) clearance for the GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL). This device is classified as a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II - Special Controls, product code HIN).
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on September 1, 2011, 136 days after receiving the submission on April 18, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4150.
| 510(k) Number | K111059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2011 |
| Decision Date | September 01, 2011 |
| Days to Decision | 136 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 |