Cleared Traditional

K112191 - HEALEX BIOSPONGE WOUND DRESSING

K112191 · Bionova Medical, Inc. · General & Plastic Surgery device
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Jun 2012
Decision
312d
Days
-
Risk

K112191 is an FDA 510(k) clearance for the HEALEX BIOSPONGE WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Bionova Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bionova Medical, Inc. devices

FDA 510(k) Submission Details - K112191

510(k) Number K112191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date June 05, 2012
Days to Decision 312 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
197d slower than avg
Panel avg: 115d · This submission: 312d
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 96
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K112191.
Collagen Dental Wound Dressings
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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
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008