FDA 510(k) Application Details - K161003

Device Classification Name	More FDA Info for this Device
510(K) Number	K161003
Device Name	EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee
Applicant	BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	VIRGINIA GARCIA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2016
Decision Date	06/17/2016
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
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