FDA 510(k) Application Details - K201001

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K201001
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	KARL STORZ Endoscopy America 2151 E Grand Avenue El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Winkie Wong 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	04/16/2020
Decision Date	03/30/2021
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