Cleared Traditional

TOPKIN WOUND DRESSING (K031684) - FDA 510(k) Clearance

K031684 · Biomet Merck GmbH · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
153d
Days
-
Risk

K031684 is an FDA 510(k) clearance for the TOPKIN WOUND DRESSING. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Biomet Merck GmbH (Ried Bei Kerzers, CH). The FDA issued a Cleared decision on October 30, 2003 after a review of 153 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.

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Submission Details

510(k) Number K031684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2003
Decision Date October 30, 2003
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.