Clearance Summary
2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP received FDA 510(k) clearance under submission number K862689, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1986-09-02.
- Submission: K862689
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1986-09-02
Classification & Regulation
This clearance is catalogued under FDA product code HXX and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.