Cleared Traditional

AONGEN COLLAGEN MATRIX (K080868) - FDA 510(k) Clearance

K080868 · Aeon Astron Europe B.V. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
412d
Days
-
Risk

K080868 is an FDA 510(k) clearance for the AONGEN COLLAGEN MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Aeon Astron Europe B.V. (Leiden, NL). The FDA issued a Cleared decision on May 14, 2009 after a review of 412 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 Aeon Astron Europe B.V. devices

Submission Details

510(k) Number K080868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2008
Decision Date May 14, 2009
Days to Decision 412 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
297d slower than avg
Panel avg: 115d · This submission: 412d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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