K102802 is an FDA 510(k) clearance for the INTEGRA ELECTRODE TUNNELING NEEDLE. This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on November 23, 2010, 57 days after receiving the submission on September 27, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K102802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2010 |
| Decision Date | November 23, 2010 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYC — Electrode, Cortical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1310 |