FDA 510(k) Application Details - K211847

Device Classification Name	More FDA Info for this Device
510(K) Number	K211847
Device Name	AdVance XP Male Sling System
Applicant	Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Anuja Bhatt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2021
Decision Date	12/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review