Cleared Special

ologen Collagen Matrix (K173223) - FDA 510(k) Clearance

K173223 · Aeon Astron Europe B.V. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Aeon Astron Europe B.V. devices

Submission Details

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.

Device Classification

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

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

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K173223.
SURECELL Gelling Fiber Wound Dressing
K173005 · Jiangsu Newvalue Medical Producst Co.,Ltd · May 2018
Cytal Wound Particulate
K180776 · Acell, Inc. · May 2018
XCelliStem Wound Powder
K172593 · Stemsys · Mar 2018
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006