Cleared Special

K173223 - ologen Collagen Matrix

K173223 · Aeon Astron Europe B.V. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
150d
Days
-
Risk

K173223 is an FDA 510(k) clearance for the ologen 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 March 2, 2018 after a review of 150 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173223

510(k) Number K173223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2017
Decision Date March 02, 2018
Days to Decision 150 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

KGN Device Classification - Class 0,

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

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

All 182
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