FDA 510(k) Application Details - K242922

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K242922
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	Shenzhen Wikkon Precision Technologies Co., Ltd. Room 1503, 15th Floor, Building A, Chuanglingtong Science and Technology Building, No.1 Shihua Road, Futian Bonded Are Shenzhen 518026 CN Other 510(k) Applications for this Company
Contact	Jack Kong Other 510(k) Applications for this Contact
Regulation Number	876.5990   More FDA Info for this Regulation Number
Classification Product Code	LNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2024
Decision Date	06/18/2025
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