Nicolet EDX
FDA 510(k) K243982 · Natus Neurology Incorporated
510(k) numberK243982
Submission
- Device name
- Nicolet EDX
- Applicant
- Natus Neurology Incorporated
Middleton, WI, US - Received
- December 23, 2024
- Decision date
- January 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional | Inomed Medizintechnik GmbH | 01/07/2022SE |
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Questions and answers
When was Nicolet EDX cleared by the FDA?
Nicolet EDX (K243982) received a 510(k) decision of Substantially Equivalent on January 22, 2025, 30 days after the submission was received.
What is the product code of K243982?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.