FDA 510(k) Application Details - K183428

Device Classification Name	Forceps, Biopsy, Electric   More FDA Info for this Device
510(K) Number	K183428
Device Name	Forceps, Biopsy, Electric
Applicant	STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Eileen McCafferty Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2018
Decision Date	04/16/2019
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