Cleared Traditional

K130997 - NEOVEIL (FDA 510(k) Clearance)

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

K130997 · Gunze Limited · General & Plastic Surgery device
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Nov 2013
Decision
219d
Days
Class 2
Risk

K130997 is an FDA 510(k) clearance for the NEOVEIL. Classified as Mesh, Surgical, Absorbable, Staple Line Reinforcement (product code OXC), Class II - Special Controls.

Submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on November 15, 2013 after a review of 219 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.

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Submission Details

510(k) Number K130997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2013
Decision Date November 15, 2013
Days to Decision 219 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
105d slower than avg
Panel avg: 114d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
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 - OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement

All 8
Devices cleared under the same product code (OXC) and FDA review panel - the closest regulatory comparables to K130997.
ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
K252906 · Ethicon Endo-Surgery, LLC · Jan 2026
Standard Staple-Line Reinforcement (SSLR23)
K231603 · Standard Bariatrics, Inc. · Oct 2023
ECHELON ENDOPATH Staple Line Reinforcement
K221343 · Ethicon Endo-Surgery, LLC · Sep 2022
NEOVEIL Staple Line Reinforcement
K221487 · Gunze Limited · Aug 2022