FDA 510(k) Application Details - K223095

Device Classification Name	System,Surgical,Computer Controlled Instrument   More FDA Info for this Device
510(K) Number	K223095
Device Name	System,Surgical,Computer Controlled Instrument
Applicant	Asensus Surgical, Inc. 1 TW Alexander Drive, Suite 160 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Casey Hinckley Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	03/16/2023
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