Cleared Special

K250824 - Percuflex Ureteral Stent (FDA 510(k) Clearance)

Also includes:

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

K250824 · Boston Scientific Corporation · Gastroenterology & Urology device

Apr 2025

Decision

28d

Days

Class 2

Risk

K250824 is an FDA 510(k) clearance for the Percuflex Ureteral Stent. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).

Submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on April 15, 2025, 28 days after receiving the submission on March 18, 2025.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.

Submission Details

510(k) Number	K250824 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 2025
Decision Date	April 15, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF