K091762 is an FDA 510(k) clearance for the DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on December 22, 2009, 189 days after receiving the submission on June 16, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K091762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2009 |
| Decision Date | December 22, 2009 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |