FDA 510(k) Application Details - K181668

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K181668
Device Name	Staple, Implantable
Applicant	Via Surgical Ltd. Mitzpe Kineret Street 22/1 Moshav Amirim 2011500 IL Other 510(k) Applications for this Company
Contact	Ofek Levin Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2018
Decision Date	03/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review