FDA 510(k) Application Details - K192043

Device Classification Name	More FDA Info for this Device
510(K) Number	K192043
Device Name	AXIOS Stent and Electrocautery Enhanced Delivery System
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Kayla Mackey Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2019
Decision Date	08/26/2019
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