FDA 510(k) Application Details - K232406

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K232406
Device Name	Endoscopic Central Control Unit
Applicant	Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 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	ODA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2023
Decision Date	10/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review