Cleared Traditional

K171231 - Endoform Topical Matrix

K171231 · Aroa Biosurgery · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
48d
Days
-
Risk

K171231 is an FDA 510(k) clearance for the Endoform Topical Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Aroa Biosurgery (Mangere, NZ). The FDA issued a Cleared decision on June 14, 2017 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aroa Biosurgery devices

FDA 510(k) Submission Details - K171231

510(k) Number K171231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date June 14, 2017
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

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 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K171231.
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MicroMatrix
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Collagen Dental Wound Dressings
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MicroMatrix
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Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015