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C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151386

by Atrium Medical Corporation

Identifiers

510(k) Number
K151386 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 series comprises surgical meshes designed for hernia repair and soft tissue reinforcement. These devices are classified as polymeric surgical meshes, intended for use in general and plastic surgery procedures to provide structural support to weakened or damaged tissues, reducing the risk of recurrence in hernia repairs.

These meshes are supplied sterile and intended for single-use. They are classified as Class II devices under FDA regulations (878.3300) and have received 510(k) clearance through a traditional review pathway. Each variant—C-QUR FX, TacShield, V-Patch, CentriFX, and Mosaic—may vary in size, shape, or material composition to address specific clinical needs, though all adhere to the same core surgical mesh category. No MRI safety information is specified.

Frequently asked questions

Are the C-QUR meshes reusable or intended for single-use only, and how should they be handled after opening?

The C-QUR series meshes are explicitly designed for single-use only. Since they are supplied sterile, they should not be reused or reprocessed. After opening, any unused portion must be discarded to maintain sterility and prevent contamination, as reuse could compromise patient safety and device integrity.

What types of surgical procedures are the C-QUR meshes primarily intended to support, and how do the variants differ?

The C-QUR meshes are polymeric surgical meshes intended for hernia repair and soft tissue reinforcement in general and plastic surgery. While all variants share the same core purpose, they vary by size, shape, or material composition to address specific clinical needs—such as inguinal, ventral, or incisional hernias—though exact differences require consulting the product-specific documentation.

How are the C-QUR meshes regulated, and what does the FDA’s 510(k) clearance mean for their use?

The C-QUR series is classified as a Class II device under FDA regulation 878.3300 and has received 510(k) clearance through a traditional review pathway. This means the FDA has determined these meshes are substantially equivalent to a legally marketed predicate device, confirming their safety and effectiveness for the intended surgical applications in hernia repair and soft tissue reinforcement.

Do any of the C-QUR variants have unique features or are they all identical in function?

While all C-QUR variants (e.g., C-QUR FX, TacShield, V-Patch, CentriFX, Mosaic) belong to the same surgical mesh category, they differ in size, shape, or material composition to cater to distinct clinical scenarios. For example, some may be optimized for specific hernia types or anatomical locations, but none alter the fundamental purpose of providing structural support to weakened tissues.

What storage conditions should be followed for the C-QUR meshes to ensure they remain sterile and effective?

The C-QUR meshes are supplied sterile, but specific storage instructions aren’t detailed in the provided data. Generally, surgical meshes should be stored in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Always refer to the manufacturer’s packaging or accompanying documentation for precise storage guidelines to maintain sterility and integrity.

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, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR ..., C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR ..., C-QUR Mesh — Atrium Hernia Mesh Recalls & Lawsuits

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrium Medical Corporation

Sources (1)

  • FDA 510(k) K151386 24 fields · synced Oct 6, 2026