FDA 510(k) Application Details - K163614

Device Classification Name	Duodenoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K163614
Device Name	Duodenoscope And Accessories, Flexible/Rigid
Applicant	PENTAX Medical 3 Paragon Drive Montvale, NJ 07645 US Other 510(k) Applications for this Company
Contact	Kanchana Iyer Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	09/20/2017
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