Cleared Traditional

K140820 - XENOMEM WOUND MATRIX

K140820 · Viscus Biologics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
451d
Days
-
Risk

K140820 is an FDA 510(k) clearance for the XENOMEM WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Viscus Biologics, LLC (Stillwater, US). The FDA issued a Cleared decision on June 26, 2015 after a review of 451 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.

View all Viscus Biologics, LLC devices

Submission Details

510(k) Number K140820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date June 26, 2015
Days to Decision 451 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
336d slower than avg
Panel avg: 115d · This submission: 451d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

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