FDA 510(k) Application Details - DEN230078

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230078
Device Name	Versius Surgical System
Applicant	CMR Surgical Limited 1 Evolution Business Park, Milton Road Cambridge CB24 9NG GB Other 510(k) Applications for this Company
Contact	Chris Weatherall Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2023
Decision Date	10/11/2024
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review