FDA 510(k) Application Details - K123438

Device Classification Name	Endoscopic Guidewire, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K123438
Device Name	Endoscopic Guidewire, Gastroenterology-Urology
Applicant	XENOLITH MEDICAL Hahadas 9 PO Box 241 Or Akiva 3065201 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	11/08/2012
Decision Date	01/10/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review