FDA 510(k) Application Details - K232405

Device Classification Name	Endoscope Holder   More FDA Info for this Device
510(K) Number	K232405
Device Name	Endoscope Holder
Applicant	AKTORmed GmbH Neugablonzer Strasse 13 Neutraubling 93073 DE Other 510(k) Applications for this Company
Contact	Hanna Kafurke Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2023
Decision Date	04/25/2024
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