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C-QUR Edge Mesh V-Patch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080691

by Atrium Medical Corp.

Identifiers

510(k) Number
K080691 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 C-QUR Edge Mesh V-Patch is a polymeric surgical mesh device. It functions as a nonabsorbable supportive scaffold for fascial tissue, providing reinforcement in hernia repair, chest wall reconstruction, and the management of surgical or traumatic wounds.

This device is intended for use by surgeons in clinical or operating room settings. It is authorized under FDA 510(k) K080691.

Frequently asked questions

What is the C-QUR Edge Mesh V-Patch used for?

This device is a nonabsorbable supportive scaffold designed for fascial tissue reinforcement. It is indicated for use in hernia repair, chest wall reconstruction, and the management of surgical or traumatic wounds.

Who is the intended user for this surgical mesh?

The C-QUR Edge Mesh V-Patch is intended for use by surgeons operating within clinical or operating room settings.

What is the regulatory status of this device?

The C-QUR Edge Mesh V-Patch is authorized under FDA 510(k) number K080691.

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: C-QUR EDGE MESH V-PATCH (K080691) — FDA 510 (k) | Innolitics, C-QUR EDGE MESH V-PATCH 510 (k) K080691 - FDA.report, C-QUR Mesh — Atrium Hernia Mesh Recalls & Lawsuits - Drugwatch

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrium Medical Corp.

Sources (1)

  • FDA 510(k) K080691 24 fields · synced Sep 22, 2026