FDA 510(k) Application Details - K152035

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K152035
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	United States Endoscopy Group, Inc 5976 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Carroll Martin Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2015
Decision Date	10/15/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review