FDA 510(k) Application Details - K203322

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K203322
Device Name	Dislodger, Stone, Biliary
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01749 US Other 510(k) Applications for this Company
Contact	Lindsay Forys Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	LQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2020
Decision Date	05/26/2021
Decision	SESE - SUBST EQUIV
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