FDA 510(k) Application Details - K121309

Device Classification Name	More FDA Info for this Device
510(K) Number	K121309
Device Name	ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
Applicant	ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW COLUMBIA SQUARE WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN KAHAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2012
Decision Date	09/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review