Cleared Traditional

CLO-SURPLUS P.A.D. (K092552) - FDA 510(k) Clearance

K092552 · Scion Cardio-Vascular, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2009
Decision
15d
Days
-
Risk

K092552 is an FDA 510(k) clearance for the CLO-SURPLUS P.A.D.. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Scion Cardio-Vascular, Inc. (Miami, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scion Cardio-Vascular, Inc. devices

Submission Details

510(k) Number K092552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date September 04, 2009
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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

All 126
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