FDA 510(k) Application Details - K232370

Device Classification Name	Kit, Nephroscope   More FDA Info for this Device
510(K) Number	K232370
Device Name	Kit, Nephroscope
Applicant	Karl Storz SE & Co. Kg Dr.-Karl-Storz-Stra▀e 34 Baden-Wurttemberg Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Alita McElroy Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2023
Decision Date	05/01/2024
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