510(k) Report

FDA applicant

Coag Medical, LLC

St. Paul, MN1 decision2014–20140 recalls

FDA records 1 decision for Coag Medical, LLC (St. Paul, MN) in 2014: 1 510(k) clearance. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Coag Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Coag Medical, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC · 20141cites it

What has FDA decided for it lately?

  • K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC · 2014

The one decision as Coag Medical, LLC →