Clearance Summary
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set received FDA 510(k) clearance under submission number K250824, sponsored by Boston Scientific Corporation. 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 2025-04-15.
- Submission: K250824
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 2025-04-15
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.