Clearance Summary
Y WIRE 2 received FDA 510(k) clearance under submission number K140576, sponsored by Safewire, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-05-20.
- Submission: K140576
- Applicant / Sponsor: Safewire, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2014-05-20
Classification & Regulation
This clearance is catalogued under FDA product code HXI and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.