510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172155Substantially Equivalent

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing

Statguard, LLC, Gladstone OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172155 is the FDA 510(k) clearance record for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing, cleared for Statguard, LLC on under FDA product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics). FDA's definition for product code QSY reads: "To temporarily control bleeding and cover external wounds". FDA records list one 510(k) clearance for Statguard, LLC. As of , FDA records show no recalls naming K172155.

Clearance record

Decision date
Received
(269 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Statguard, LLC 7555 Cason Ln., Gladstone OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSY

Trailing 12 months
4 clearances under product code QSY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QSY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260