Clearance Summary
iGPS Navigation Instruments received FDA 510(k) clearance under submission number K251780, sponsored by SI-BONE, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-09-15.
- Submission: K251780
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-09-15
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.