FDA 510(k) Application Details - K190164

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K190164
Device Name	Endoscope Channel Accessory
Applicant	Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772-2104 US Other 510(k) Applications for this Company
Contact	Mary Anne Patella Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2019
Decision Date	04/04/2019
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