FDA 510(k) Application Details - K202583

Device Classification Name	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula   More FDA Info for this Device
510(K) Number	K202583
Device Name	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant	Steris Corporation 5976 Heisley Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Jacqueline Oliver Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2020
Decision Date	11/06/2020
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