FDA 510(k) Application Details - DEN240018

Device Classification Name	Accessories, Cleaning, For Endoscope   More FDA Info for this Device
510(K) Number	DEN240018
Device Name	Accessories, Cleaning, For Endoscope
Applicant	Nanosonics Limited 7-11 Talavera Road Macquarie Park 2113 AU Other 510(k) Applications for this Company
Contact	Nancy Kaiser Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2024
Decision Date	03/19/2025
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review