FDA 510(k) Application Details - K181451

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K181451
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-Shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2018
Decision Date	01/16/2019
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