K010969 is an FDA 510(k) clearance for the NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on April 20, 2001, 18 days after receiving the submission on April 2, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K010969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2001 |
| Decision Date | April 20, 2001 |
| Days to Decision | 18 days |
| Submission Type | Special |
| 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 |