Cleared Traditional

CLO-SURPLUSP.A.D. (K032986) - FDA 510(k) Clearance

K032986 · Scion Cardio-Vascular, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
159d
Days
-
Risk

K032986 is an FDA 510(k) clearance for the CLO-SURPLUSP.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 March 1, 2004 after a review of 159 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 Scion Cardio-Vascular, Inc. devices

Submission Details

510(k) Number K032986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date March 01, 2004
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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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