FDA 510(k) Application Details - K230658

Device Classification Name	More FDA Info for this Device
510(K) Number	K230658
Device Name	SKOUT« system
Applicant	Iterative Scopes Inc. 675 Massachusetts Ave 2nd Floor Cambridge, MA 02139 US Other 510(k) Applications for this Company
Contact	Dennis Francoeur 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	03/09/2023
Decision Date	04/07/2023
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