FDA 510(k) Application Details - DEN230025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230025
Device Name	MIRA Surgical System
Applicant	Virtual Incision 2125 Transformation Drive, Suite 1300 Lincoln, NE 68508 US Other 510(k) Applications for this Company
Contact	Florence Beck Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2023
Decision Date	02/23/2024
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