510(k) K263010
K263010 is an FDA 510(k) premarket notification submitted by Inomed Medizintechnik GmbH for the device "ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Inomed Medizintechnik GmbH has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 2026
- Date Received
- Aug 28, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type
- 510(k)