Clearance Summary
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT received FDA 510(k) clearance under submission number K913928, sponsored by Surgitek Medical Engineering Corp.. 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 1991-11-19.
- Submission: K913928
- Applicant / Sponsor: Surgitek Medical Engineering Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 1991-11-19
Classification & Regulation
This clearance is catalogued under FDA product code FAD and 21 CFR 876.4620, within the Gastroenterology, Urology review panel as a Class II device.