FDA 510(k) Application Details - K240192

Device Classification Name	Dislodger, Stone, Biliary   More FDA Info for this Device
510(K) Number	K240192
Device Name	Dislodger, Stone, Biliary
Applicant	Scivita Medical Technology Co., Ltd. No. 2, Qingqiu Street, Suzhou Industrial Park Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Wu Ruqin 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	01/24/2024
Decision Date	10/15/2024
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