FDA 510(k) Application Details - K241168

Device Classification Name	Accessories, Cleaning, For Endoscope   More FDA Info for this Device
510(K) Number	K241168
Device Name	Accessories, Cleaning, For Endoscope
Applicant	Wassenburg Medical, Inc. 144 Railroad Drive Ivyland, PA 18974 US Other 510(k) Applications for this Company
Contact	Mario Infanti 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	04/26/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review