FDA 510(k) Application Details - K113692

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K113692
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	XENOLITH MEDICAL 1 LESHEM, P.O. BOX 720 KITYAT-GAT 82000 IL Other 510(k) Applications for this Company
Contact	OFER ZIGMAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2011
Decision Date	08/09/2012
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