Submission Details
| 510(k) Number | K050325 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
May 2005
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K050325 is an FDA 510(k) clearance for the DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE, 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 review panel. Regulated under 21 CFR 882.1350.
Device Classification
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1350 |
Manufacturer
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