Clearance Summary
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) received FDA 510(k) clearance under submission number K964061, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1997-02-20.
- Submission: K964061
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-02-20
Classification & Regulation
This clearance is catalogued under FDA product code LYK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.