Cleared Traditional

K130852 - AVANCE® FOAM ABDOMINAL DRESSING KIT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130852 · Molnlycke Health Care · General & Plastic Surgery device
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Apr 2014
Decision
382d
Days
Class 2
Risk

K130852 is an FDA 510(k) clearance for the AVANCE® FOAM ABDOMINAL DRESSING KIT. Classified as Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects (product code OXJ), Class II - Special Controls.

Submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on April 14, 2014 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. 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.

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Submission Details

510(k) Number K130852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date April 14, 2014
Days to Decision 382 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
268d slower than avg
Panel avg: 114d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXJ Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Abdominal Wall Defects.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.