Cleared Traditional

K082869 - AWBAT-S, AWBAT-D, AWBAT-M

K082869 · Aubrey, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
130d
Days
-
Risk

K082869 is an FDA 510(k) clearance for the AWBAT-S, AWBAT-D, AWBAT-M. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Aubrey, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Aubrey, Inc. devices

FDA 510(k) Submission Details - K082869

510(k) Number K082869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date February 06, 2009
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
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)

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