FDA 510(k) Application Details - K203550

Device Classification Name	More FDA Info for this Device
510(K) Number	K203550
Device Name	ActivSight Intraoperative Imaging System
Applicant	Activ Surgical, Inc. 840 Summer Street Boston, MA 02127 US Other 510(k) Applications for this Company
Contact	Matthew King 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	12/04/2020
Decision Date	04/08/2021
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