Clearance Summary
ArtiFascia received FDA 510(k) clearance under submission number K223445, sponsored by Nurami Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-08-10.
- Submission: K223445
- Applicant / Sponsor: Nurami Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 2023-08-10
Classification & Regulation
This clearance is catalogued under FDA product code GXQ and 21 CFR 882.5910, within the Neurology review panel as a Class II device.