510(k) K140576
K140576 is an FDA 510(k) premarket notification submitted by Safewire, LLC for the device "Y WIRE 2". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code HXI (Passer, Wire, Orthopedic), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2014
- Date Received
- March 6, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Passer, Wire, Orthopedic
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type