STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM— 510(k) K140313

Name: FDA 510(k) clearance K140313
Creator: U.S. Food and Drug Administration
Published: 2014-07-28

Substantially Equivalent

Coag Medical, LLC

FDA 510(k) clearance K140313 for STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM, Substantially Equivalent on 2014-07-28. Applicant: Coag Medical, LLC. Device class: Unclassified.

Clearance details

Applicant: Coag Medical, LLC
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2014-02-10
Decision date: 2014-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSY

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K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)2026-04-30
K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
K250319 — MFUSE (MS001)2025-12-15
K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240713 — TRAUMAGEL®2024-08-14

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.