FDA 510(k) Application Details - K171208

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K171208
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz 49348 IL Other 510(k) Applications for this Company
Contact	Alex Chanin Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2017
Decision Date	02/05/2018
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