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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K250824
Device Name 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
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Urology And Pelvic Health Division
Marlborough,  MA  01752
Applicant Contact Stephanie Anderson
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Urology And Pelvic Health Division
Marlborough,  MA  01752
Correspondent Contact Stephanie Anderson
Regulation Number876.4620
Classification Product Code
FAD  
Subsequent Product Code
LJE  
Date Received03/18/2025
Decision Date 04/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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