FDA 510(k) Application Details - K251126

Device Classification Name	More FDA Info for this Device
510(K) Number	K251126
Device Name	SKOUT system
Applicant	Iterative Health 14 Arrow Street, Floor 3 Cambridge, MA 02138 US Other 510(k) Applications for this Company
Contact	Caitlyn Seidl 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	04/11/2025
Decision Date	05/09/2025
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