Clearance Summary
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance under submission number K233292, sponsored by Inomed Medizintechnik GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-10-27.
- Submission: K233292
- Applicant / Sponsor: Inomed Medizintechnik GmbH
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2023-10-27
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.