FDA 510(k) Application Details - K231344

Device Classification Name	More FDA Info for this Device
510(K) Number	K231344
Device Name	ActivSight Intraoperative Imaging System
Applicant	Activ Surgical Inc. 30 Thomson Place Boston, MA 02110 US Other 510(k) Applications for this Company
Contact	Nicholas Child Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2023
Decision Date	08/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review