FDA 510(k) Application Details - K243075

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K243075
Device Name	Endoscope Channel Accessory
Applicant	Steris Corporation 14605 28th Avenue North Minneapolis, MN 55447 US Other 510(k) Applications for this Company
Contact	Disha Kabrawala Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	11/08/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review