K034012 is an FDA 510(k) clearance for the SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE. This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on March 16, 2004, 83 days after receiving the submission on December 24, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K034012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2003 |
| Decision Date | March 16, 2004 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXI — Probe, Radiofrequency Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4725 |