FDA 510(k) Application Details - K172734

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K172734
Device Name	Snare, Flexible
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2017
Decision Date	12/07/2017
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