Clearance Summary
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO received FDA 510(k) clearance under submission number K990765, sponsored by Flexmedics. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1999-03-15.
- Submission: K990765
- Applicant / Sponsor: Flexmedics
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1999-03-15
Classification & Regulation
This clearance is catalogued under FDA product code OCY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.