K102523 is an FDA 510(k) clearance for the MULTI-LEAD TRIALING CABLE MODEL 355531. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 26, 2010, 54 days after receiving the submission on September 2, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K102523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2010 |
| Decision Date | October 26, 2010 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |