FDA 510(k) Application Details - K161186

Device Classification Name	Forceps, Biopsy, Electric   More FDA Info for this Device
510(K) Number	K161186
Device Name	Forceps, Biopsy, Electric
Applicant	FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	SHRADDHA MORE 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	04/27/2016
Decision Date	06/29/2016
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