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510(k) K253290

XSTAT P15 by Revmedx, Inc. — Product Code PGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 12, 2025
Date Received: September 29, 2025
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.