K130489 is an FDA 510(k) clearance for the ELECTRODE, FLEXIBLE SUCTION COAGULATOR. This device is classified as a Electrode, Flexible Suction Coagulator (Class II - Special Controls, product code FEH).
Submitted by Optim, LLC (Sturbridge, US). The FDA issued a Cleared decision on April 19, 2013, 53 days after receiving the submission on February 25, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K130489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2013 |
| Decision Date | April 19, 2013 |
| Days to Decision | 53 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEH - Electrode, Flexible Suction Coagulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |