FDA 510(k) Application Details - K151243

Device Classification Name	Light, Catheter, Fiberoptic, Glass, Ureteral   More FDA Info for this Device
510(K) Number	K151243
Device Name	Light, Catheter, Fiberoptic, Glass, Ureteral
Applicant	Stryker Endoscopy 5900 Optical Ct SAN JOSE, CA 95138 US Other 510(k) Applications for this Company
Contact	GOLNAZ MOEINI Other 510(k) Applications for this Contact
Regulation Number	876.4020   More FDA Info for this Regulation Number
Classification Product Code	FCS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2015
Decision Date	08/20/2015
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