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Neoveil Staple Line Reinforcement

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221487

by Gunze Limited

Identifiers

510(k) Number
K221487 FDA 510(k)
FDA Product Code
OXC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neoveil Staple Line Reinforcement is a bioabsorbable surgical mesh designed to reinforce staple lines during open or minimally invasive procedures. Classified as an absorbable surgical mesh, it provides additional support to stapled tissue interfaces to potentially reduce complications such as leakage or dehiscence. Constructed from polyurethane and nylon elastic knits, it is intended for use with corresponding surgical staplers.

This device is supplied as a sterile, single-use product, comprising sleeves for both the cartridge and anvil of compatible staplers. It is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD), with a classification as a Class II device. The reinforcement is removed and discarded post-firing, leaving behind bioabsorbable polyglycolic acid (PGA) tacking threads. Multiple registration numbers and FEI numbers are associated with its distribution.

Frequently asked questions

What is the Neoveil Staple Line Reinforcement used for in surgical procedures?

The Neoveil Staple Line Reinforcement is designed to reinforce staple lines during open or minimally invasive surgeries. It provides extra support to stapled tissue interfaces, which may help reduce complications like leakage or dehiscence. The mesh is intended to be used with compatible surgical staplers and is constructed from polyurethane and nylon elastic knits, ensuring it integrates with stapling mechanisms.

Is the Neoveil Staple Line Reinforcement reusable or single-use, and how is it packaged?

The Neoveil Staple Line Reinforcement is a sterile, single-use product. It is supplied as sleeves for both the cartridge and anvil of compatible surgical staplers, ensuring it is ready for immediate use in the operating room without the need for reprocessing.

What happens to the Neoveil Staple Line Reinforcement after it is fired during surgery?

After firing, the Neoveil Staple Line Reinforcement is removed and discarded. It leaves behind bioabsorbable polyglycolic acid (PGA) tacking threads, which gradually dissolve over time without requiring additional removal.

What regulatory pathways does the Neoveil Staple Line Reinforcement follow, and what classification does it hold?

The Neoveil Staple Line Reinforcement is regulated under the FDA 510(k) clearance process and the Medical Device Directive (MDD). It is classified as a Class II device, which indicates it has a moderate risk level and requires specific regulatory oversight to ensure safety and effectiveness.

Are there different sizes or models available for the Neoveil Staple Line Reinforcement?

The specifications provided do not list explicit size or model variations, but the device is designed to fit compatible surgical staplers. The product is supplied as sleeves for both the cartridge and anvil, implying compatibility with standard stapling systems. For precise sizing details, refer to the manufacturer’s product documentation or consult with their technical support.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEOVEIL® Staple Line Reinforcement - GUNZE Medical USA, - GUNZE Medical USA, NEOVEIL™ TUBE - GUNZE Medical Division

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gunze Limited

Sources (2)

  • FDA 510(k) K221487 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026