FDA 510(k) Application Details - K244023

Device Classification Name	More FDA Info for this Device
510(K) Number	K244023
Device Name	MAGENTIQ-COLO (ME-APDS)
Applicant	Magentiq Eye LTD 6 Ben Gurion Blvd. Haifa 3541416 IL Other 510(k) Applications for this Company
Contact	Dror Zur Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2024
Decision Date	01/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review