K093181 is an FDA 510(k) clearance for the GYRUS ACMI PK BUTTON ELECTRODE. This device is classified as a Electrode, Electrosurgical, Active, Urological (Class II - Special Controls, product code FAS).
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on February 24, 2010, 139 days after receiving the submission on October 8, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K093181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2009 |
| Decision Date | February 24, 2010 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAS — Electrode, Electrosurgical, Active, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |