FDA 510(k) Application Details - K213198

Device Classification Name	More FDA Info for this Device
510(K) Number	K213198
Device Name	Ax-Surgi Surgical Hemostat
Applicant	Advamedica Inc. Harvard Square, 1 Mifflin Place, Suite 400 Cambridge, MA 02138 US Other 510(k) Applications for this Company
Contact	Leo Mavely Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	01/05/2023
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