FDA 510(k) Application Details - K211934

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K211934
Device Name	Stent, Ureteral
Applicant	Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Liz Johnston 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	06/22/2021
Decision Date	11/10/2022
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review