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BARD SOFT MESH - 0117003

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033814

by C. R. Bard, Inc.

Identifiers

510(k) Number
K033814 FDA 510(k)
FDA Product Code
FTL FDA 510(k)
Models / Variants
0117001 FDA 510(k)
0117002 FDA 510(k)
0117003 FDA 510(k)
0117004 FDA 510(k)
0117005 FDA 510(k)
0117006 FDA 510(k)
0117007 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)

Bard Soft Mesh is a surgical polymeric mesh designed for soft tissue reinforcement. It features a knitted structure with large pores, providing flexibility and durability while minimizing fraying or unraveling when cut. The mesh is intended for use in general and plastic surgery procedures requiring reinforcement of soft tissues, such as hernia repair or other reconstructive applications.

The device is supplied in multiple models and sizes, including a 12 in x 12 in (30.5 cm x 30.5 cm) square configuration, and is intended for single-use. Bard Soft Mesh is classified as a Class II medical device under FDA regulations (878.3300) and holds a 510(k) clearance (K033814) for substantial equivalence. It is not MRI-safe, and storage conditions should follow manufacturer guidelines to maintain sterility and integrity.

Frequently asked questions

What types of surgical procedures is the Bard Soft Mesh intended to support with its reinforcement properties?

The Bard Soft Mesh is designed for soft tissue reinforcement in general and plastic surgery procedures, particularly for applications like hernia repair or other reconstructive surgeries where durable support is needed. Its knitted structure with large pores provides flexibility and minimizes fraying, making it suitable for reinforcing soft tissues during these procedures.

Is the Bard Soft Mesh reusable, or is it intended for single-use only?

The Bard Soft Mesh is explicitly intended for single-use only, as stated in the device description. This ensures sterility and safety for each surgical procedure.

What are the available sizes for the Bard Soft Mesh, and how is it packaged?

The Bard Soft Mesh is available in multiple models, including a standard size of 12 inches by 12 inches (30.5 cm x 30.5 cm) in a square configuration. The exact packaging details are not specified, but it is supplied as a sterile device for surgical use.

Can the Bard Soft Mesh be used in an MRI environment, or does it pose any risks?

The Bard Soft Mesh is explicitly stated as not MRI-safe, meaning it should not be used in an MRI environment due to potential risks associated with imaging compatibility.

How should the Bard Soft Mesh be stored to maintain its integrity and sterility?

The device must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. While specific storage conditions are not detailed, typical best practices for single-use surgical meshes—such as keeping it in a sealed, dry environment away from direct sunlight or extreme temperatures—should be followed.

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: Bard™ Soft Mesh - BD, Bard™ Soft Mesh, Square, 12 in x 12 in (30.5 cm x 30.5 cm), PDF K033814 Bard Soft Mesh, Models 0117001, 0117002,, 510(k) K033814 — BARD SOFT MESH, MODELS 0117001, 0117002, 0117003 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K033814 24 fields · synced Sep 18, 2026