K050325 is an FDA 510(k) clearance for the DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on May 5, 2005, 85 days after receiving the submission on February 9, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K050325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2005 |
| Decision Date | May 05, 2005 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |