Clearance Summary
3D-SHAPER received FDA 510(k) clearance under submission number K251022, sponsored by 3D-Shaper Medical S.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-09-05.
- Submission: K251022
- Applicant / Sponsor: 3D-Shaper Medical S.L
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2025-09-05
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.