Cleared Traditional

K140313 - STOPSBLEEDING TOPICAL HEMOSTAT POWDER A...

K140313 · Coag Medical, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2014
Decision
168d
Days
-
Risk

K140313 is an FDA 510(k) clearance for the STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Coag Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on July 28, 2014 after a review of 168 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Coag Medical, LLC devices

FDA 510(k) Submission Details - K140313

510(k) Number K140313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date July 28, 2014
Days to Decision 168 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K140313.
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K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012