Cleared Traditional

K110318 - EXCELLAGEN

K110318 · Tissue Repair Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
243d
Days
-
Risk

K110318 is an FDA 510(k) clearance for the EXCELLAGEN. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Tissue Repair Company (San Diego, US). The FDA issued a Cleared decision on October 3, 2011 after a review of 243 days - an extended review 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: 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 Tissue Repair Company devices

FDA 510(k) Submission Details - K110318

510(k) Number K110318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2011
Decision Date October 03, 2011
Days to Decision 243 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
128d slower than avg
Panel avg: 115d · This submission: 243d
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 118
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K110318.
PRIMATRIX DERMAL REPAIR SCAFFOLD
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INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012
MATRISTEM WOUND MATRIX
K112409 · Acell, Inc. · Aug 2011
ACELL MATRISTEM WOUND SHEET
K092926 · Acell, Inc. · Oct 2009
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009