Clearance Summary
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE received FDA 510(k) clearance under submission number K010303, sponsored by Artscan Medical Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-09-11.
- Submission: K010303
- Applicant / Sponsor: Artscan Medical Innovations
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2001-09-11
Classification & Regulation
This clearance is catalogued under FDA product code NGR and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.