Cleared Traditional

SORBASTACE (K965034) - FDA 510(k) Clearance

K965034 · Hemostace, LLC · General & Plastic Surgery device
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Apr 1998
Decision
478d
Days
-
Risk

K965034 is an FDA 510(k) clearance for the SORBASTACE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemostace, LLC (Rockville, US). The FDA issued a Cleared decision on April 9, 1998 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K965034 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 17, 1996
Decision Date April 09, 1998
Days to Decision 478 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
363d slower than avg
Panel avg: 115d · This submission: 478d
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.