FDA 510(k) Application Details - K121370

Device Classification Name	Pneumoperitoneum Needle   More FDA Info for this Device
510(K) Number	K121370
Device Name	Pneumoperitoneum Needle
Applicant	VECTEC 2995 STEVEN MARTIN DR. FAIRFAX, VA 22031 US Other 510(k) Applications for this Company
Contact	Diane Horwitz Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2012
Decision Date	08/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review