FDA 510(k) Application Details - K163455

Device Classification Name	More FDA Info for this Device
510(K) Number	K163455
Device Name	SurgiCube
Applicant	SURGICUBE INTERNATIONAL B.V. SEGGELANT-NOORD 4 VIERPOLDERS 3237 MG NL Other 510(k) Applications for this Company
Contact	GER VIJFVINKEL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2016
Decision Date	09/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review