FDA 510(k) Application Details - K250824

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K250824
Device Name	Stent, Ureteral
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Urology and Pelvic Health Division Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Stephanie Anderson Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2025
Decision Date	04/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review