Home / 510(k) Clearances / K180051

510(k) K180051

XSTAT 30, 1-Pack by Revmedx, Inc. — Product Code PGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 18, 2018
Date Received: January 8, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device Class: Class II
Regulation Number: 878.4452
Review Panel: SU
Submission Type

To control bleeding in junctional, non-compressible wounds until surgical care is acquired.