FDA 510(k) Application Details - DEN180062

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180062
Device Name	EchoTip Insight Portosystemic Pressure Gradient Measuring System
Applicant	Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick IE Other 510(k) Applications for this Company
Contact	Jane Kennedy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2018
Decision Date	11/20/2019
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review