Submission Details
| 510(k) Number | K241045 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 2024 |
| Decision Date | December 11, 2024 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Disposable Subdermal Needle Electrode, Corkscrew
Dec 2024
Decision
238d
Days
Class 2
Risk
About This 510(k) Submission
K241045 is an FDA 510(k) clearance for the Disposable Subdermal Needle Electrode, Corkscrew, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on December 11, 2024, 238 days after receiving the submission on April 17, 2024. 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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