FDA 510(k) Application Details - K183590

Device Classification Name	More FDA Info for this Device
510(K) Number	K183590
Device Name	Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
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	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	08/01/2019
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