FDA 510(k) Application Details - K182421

Device Classification Name	System,Surgical,Computer Controlled Instrument   More FDA Info for this Device
510(K) Number	K182421
Device Name	System,Surgical,Computer Controlled Instrument
Applicant	TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville, NC 27650 US Other 510(k) Applications for this Company
Contact	Stephanie M. Fitts 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	09/05/2018
Decision Date	01/11/2019
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