Submission Details
| 510(k) Number | K130136 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 18, 2013 |
| Decision Date | July 19, 2013 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
Jul 2013
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K130136 is an FDA 510(k) clearance for the DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on July 19, 2013, 182 days after receiving the submission on January 18, 2013. 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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