Cleared Traditional

K061314 - BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (FDA 510(k) Clearance)

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

K061314 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
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Jun 2006
Decision
22d
Days
Class 2
Risk

K061314 is an FDA 510(k) clearance for the BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on June 2, 2006 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davol Inc., Sub. C. R. Bard, Inc. devices

Submission Details

510(k) Number K061314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date June 02, 2006
Days to Decision 22 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
92d faster than avg
Panel avg: 114d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 334
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