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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
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