FDA 510(k) Application Details - K211325

Device Classification Name	System,Surgical,Computer Controlled Instrument   More FDA Info for this Device
510(K) Number	K211325
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	Taylor Fisher 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	04/30/2021
Decision Date	07/27/2021
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