Clearance Summary
FLEX-I-GRASP received FDA 510(k) clearance under submission number K854889, sponsored by Euro-Med Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1986-02-21.
- Submission: K854889
- Applicant / Sponsor: Euro-Med Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1986-02-21
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.