K100418 is an FDA 510(k) clearance for the SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE. 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 September 3, 2010, 199 days after receiving the submission on February 16, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K100418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2010 |
| Decision Date | September 03, 2010 |
| Days to Decision | 199 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 |