FDA 510(k) Application Details - K244001

Device Classification Name	Cystourethroscope   More FDA Info for this Device
510(K) Number	K244001
Device Name	Cystourethroscope
Applicant	KARL STORZ SE & CO. KG Dr.-Karl-Storz-Stra▀e 34 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Thomas Ostrowski Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2024
Decision Date	05/02/2025
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