FDA 510(k) Application Details - K243807

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K243807
Device Name	Dislodger, Stone, Biliary
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachiochi-shi 192-0032 JP Other 510(k) Applications for this Company
Contact	Seiko Yunoki Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	LQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2024
Decision Date	03/18/2025
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