510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253290Substantially Equivalent

Xstat P15

Revmedx Inc, Wilsonville OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253290 is the FDA 510(k) clearance record for XSTAT P15, a class II device, cleared for Revmedx, Inc. on under FDA product code PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use). FDA's definition for product code PGZ reads: "To control bleeding in junctional, non-compressible wounds until surgical care is acquired". FDA records list 7 510(k) clearances for Revmedx, Inc., from to . As of , FDA records show no recalls naming K253290.

Clearance record

Decision date
Received
(44 days to decision)
Product code
PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Regulation
21 CFR 878.4452
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Revmedx, Inc. 25749 S W Canyon Creek Rd., Wilsonville OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGZ

Trailing 12 months
1 clearance under product code PGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260