FDA 510(k) Application Details - K241508

Device Classification Name	More FDA Info for this Device
510(K) Number	K241508
Device Name	SKOUT« system
Applicant	Iterative Scopes, Inc. 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	05/28/2024
Decision Date	07/03/2024
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