Clearance Summary
GORE SMOOTHER II AND GORE BPTB received FDA 510(k) clearance under submission number K941269, 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 1994-05-19.
- Submission: K941269
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1994-05-19
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.