FDA 510(k) Application Details - K211223

Device Classification Name	More FDA Info for this Device
510(K) Number	K211223
Device Name	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant	Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Rachel Nankervis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2021
Decision Date	07/21/2021
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