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PGZ

Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Product code
PGZ
Device name
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device class
Class 2
21 CFR
21 CFR 878.4452
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-12.

NumberDecision dateApplicantDevice nameSummary
K2532902025-11-12Revmedx, Inc.XSTAT P15PDF

1 summaries are archived here for direct download.

Official FDA classification page: PGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).