Cleared Traditional

K112888 - MESO WOUND MATRIX

K112888 · Kensey Nash Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
133d
Days
-
Risk

K112888 is an FDA 510(k) clearance for the MESO WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kensey Nash Corporation (Exton, US). The FDA issued a Cleared decision on February 10, 2012 after a review of 133 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 Kensey Nash Corporation devices

FDA 510(k) Submission Details - K112888

510(k) Number K112888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date February 10, 2012
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 K112888.
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
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