FDA 510(k) Application Details - K132151

Device Classification Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)   More FDA Info for this Device
510(K) Number	K132151
Device Name	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant	MEDIGUS, LTD. 555 13TH STREET, NW COLUMBIA SQUARE WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2013
Decision Date	03/19/2014
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