K032601 is an FDA 510(k) clearance for the STRYKER INTERVENTIONAL PAIN RF GENERATOR. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Valley Forge Scientific Corp. (Oaks, US). The FDA issued a Cleared decision on April 1, 2004, 220 days after receiving the submission on August 25, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K032601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2003 |
| Decision Date | April 01, 2004 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXD — Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |