FDA 510(k) Application Details - K242960

Device Classification Name	More FDA Info for this Device
510(K) Number	K242960
Device Name	AdVanceÖ XP Male Sling System (720163-03)
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Natalie Asprey 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	09/25/2024
Decision Date	11/15/2024
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