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Surgimesh WN

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061445

by Aspide Medical

Identifiers

510(k) Number
K061445 FDA 510(k)
FDA Product Code
FTL 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 Surgimesh WN is a surgical mesh device classified as a Polymeric Surgical Mesh, designed for use in hernia repair and abdominal reinforcement procedures. It is constructed from a non-barrier textile material intended to provide structural support to weakened or damaged tissues, facilitating tissue integration and promoting healing in abdominal wall defects.

This device is supplied sterile and intended for single-use in surgical settings. It is classified under FDA product code FTL and has received FDA 510(k) clearance for use in general and plastic surgery. The mesh is available in various configurations, as referenced in the regulatory submission, and is intended for use in procedures such as umbilical hernia repair and abdominal reinforcement. No MRI safety information is specified, and storage conditions are not detailed in the provided data.

Frequently asked questions

What is the Surgimesh WN used for?

The Surgimesh WN is a polymeric surgical mesh designed specifically for hernia repair and abdominal reinforcement procedures. It provides structural support to weakened or damaged tissues, helping to facilitate tissue integration and promote healing in abdominal wall defects, such as umbilical hernia repair.

Is the Surgimesh WN intended for single-use or reuse?

The Surgimesh WN is supplied sterile and intended exclusively for single-use in surgical settings. This ensures patient safety and reduces the risk of infection or contamination associated with reuse.

What types of procedures is the Surgimesh WN approved for?

The Surgimesh WN is FDA 510(k) cleared for use in general and plastic surgery procedures, including umbilical hernia repair and abdominal reinforcement. Its design supports tissue integration and reinforcement in abdominal wall defects.

Are there different configurations or sizes available for the Surgimesh WN?

The Surgimesh WN is available in various configurations, as referenced in the regulatory submission. These configurations likely cater to different surgical needs, such as varying hernia sizes or anatomical requirements, ensuring flexibility for clinicians.

How should the Surgimesh WN be stored?

The provided data does not specify storage conditions for the Surgimesh WN. Clinicians should refer to the manufacturer’s instructions or packaging for detailed storage guidelines to maintain sterility and device integrity before use.

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: Non-Barrier Mesh - WN - SURGIMESH® Surgical Implants, BG Medical - America's Premiere Medical Device Distributor, SURGIMESH WN (K061445) — FDA 510(k) | Innolitics, ASPIDE MEDICAL,Umbilical hernia prosthesis / abdominal SURGIMESH®WN ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aspide Medical

Sources (1)

  • FDA 510(k) K061445 24 fields · synced Oct 5, 2026