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510(k) K213198

Ax-Surgi Surgical Hemostat by Advamedica, Inc. — Product Code POD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 5, 2023
Date Received: September 29, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Temporary, Internal Use Hemostatic
Device Class: Class II
Regulation Number: 878.4454
Review Panel: SU
Submission Type

Intended to control severely bleeding wounds