510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121485Substantially Equivalent

Guardiva Antimicrobial Haemstatic IV Dressing

Hemcon Medical Technologies Europe, Ltd., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121485 is the FDA 510(k) clearance record for GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING, cleared for Hemcon Medical Technologies Europe, Ltd. 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 3 510(k) clearances for Hemcon Medical Technologies Europe, Ltd., from to . As of , FDA records show no recalls naming K121485.

Clearance record

Decision date
Received
(95 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Hemcon Medical Technologies Europe, Ltd. 10575 SW Cascade Ave., Suite 130, Portland 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