Cleared Traditional

K130428 - COVAMESH

K130428 is an FDA 510(k) clearance for COVAMESH, manufactured by Biomup S.A.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K130428 · Biomup S.A. · General & Plastic Surgery device
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Oct 2013
Decision
247d
Days
Class 2
Risk

K130428 is an FDA 510(k) clearance for the COVAMESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Biomup S.A. (St-Priest, FR). The FDA issued a Cleared decision on October 25, 2013 after a review of 247 days - an extended review cycle.

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. 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 Biomup S.A. devices

FDA 510(k) Submission Details - K130428

510(k) Number K130428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2013
Decision Date October 25, 2013
Days to Decision 247 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
132d slower than avg
Panel avg: 115d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 204
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