Cleared Traditional

K142363 - NUSTAT, NUSTAT XR (FDA 510(k) Clearance)

K142363 · Beeken Biomedical · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2015
Decision
137d
Days
-
Risk

K142363 is an FDA 510(k) clearance for the NUSTAT, NUSTAT XR. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Beeken Biomedical (Raleigh, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 137 days - within the typical 510(k) review window.

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 Beeken Biomedical devices

Submission Details

510(k) Number K142363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date January 09, 2015
Days to Decision 137 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
23d slower than avg
Panel avg: 114d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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