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

This 510(k) clears multiple ureteral stent and urinary diversion stent products from Boston Scientific. Ureteral stents facilitate urinary drainage from the kidney to the bladder via endoscopic or fluoroscopic placement by a trained physician. Urinary diversion stent sets provide external drainage of urine after urinary diversion surgeries. All devices are sterile, single-use, disposable products available in various French sizes and lengths.

The proposed devices have the same technological characteristics and fundamental design as the predicate device (Tria Firm Ureteral Stent, K190603). Devices feature dual or single pigtail designs with side ports for drainage, are radiopaque for visualization, include attached retrieval sutures, and are designed to be placed over a guidewire. The urinary diversion stent measures approximately 80 cm from kidney coil to distal end with a straight body except at the kidney end.

Not stated in this summary.

The submission argues substantial equivalence based on identical intended use, operating principle, and technological characteristics between the proposed devices and predicate device. Since the changes are limited to labeling updates (clarifying indications for use to align with state-of-the-art clinical practice) with no changes to overall design, performance, operating principle, or fundamental technology, no additional verification, validation, shelf-life, sterilization, or biocompatibility testing was required. The identical principles of operation—providing a drainage lumen—mean the differences do not alter suitability for intended use.