FDA 510(k) Application Details - K173400

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K173400
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Thomas Hirte Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2017
Decision Date	02/09/2018
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