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Marlex Mesh Dart

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922916

by C. R. Bard, Inc.

Identifiers

510(k) Number
K922916 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 Marlex Mesh Dart is a surgical mesh device classified as a Polymeric Surgical Mesh under FDA product code FTL. Constructed from expanded polytetrafluoroethylene (ePTFE), this device is designed for use in hernia repair procedures, providing reinforcement to weakened abdominal walls or inguinal areas. Its porous structure facilitates tissue integration while maintaining structural integrity to support healing.

Intended for single-use applications, the Marlex Mesh Dart is supplied sterile and is regulated under FDA 510(k) clearance (K922916) as a Class II device in the General and Plastic Surgery category. It is typically implanted during open or laparoscopic hernia repair surgeries, where it is sutured or secured into place to prevent herniation. The device adheres to FDA regulation 878.3300 and is manufactured by C.R. Bard, Inc., with no third-party distribution noted.

Frequently asked questions

What is the Marlex Mesh Dart used for?

The Marlex Mesh Dart is designed specifically for hernia repair procedures. Its expanded polytetrafluoroethylene (ePTFE) construction provides reinforcement to weakened abdominal walls or inguinal areas, helping prevent herniation by supporting tissue integration and maintaining structural integrity during healing.

How is the Marlex Mesh Dart supplied and prepared for use?

The Marlex Mesh Dart is supplied sterile and intended for single-use only. It is manufactured by C.R. Bard, Inc., and does not require additional preparation beyond sterile handling prior to surgical implantation. This ensures safety and compliance with surgical standards.

Is the Marlex Mesh Dart reusable, or is it meant for one-time use?

The Marlex Mesh Dart is explicitly designed for single-use applications. Reusing it could compromise sterility and integrity, potentially leading to complications. Its intended use aligns with FDA guidelines for surgical meshes in hernia repair.

What makes the Marlex Mesh Dart different from other hernia repair meshes?

The Marlex Mesh Dart is constructed from ePTFE, which offers a unique porous structure that facilitates tissue integration while maintaining durability. Unlike some alternatives, its design prioritizes long-term support for weakened abdominal walls, making it suitable for both open and laparoscopic hernia repair procedures.

How should the Marlex Mesh Dart be stored before use?

Since the Marlex Mesh Dart is sterile upon packaging, it should be stored in its original, unopened packaging to preserve sterility. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures, as these conditions could degrade the material or compromise its integrity before surgery.

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 MARLEX MESH DART (K922916) — FDA 510 (k) | Innolitics, K922916 FDA 510 (k) - BARD MARLEX MESH DART | C.R. Bard, Inc., PDF Knight_v_CR_Bard_Inc_et_al__ohsdce-26-01237__0001.0.pdf, PDF K922916 BARD MARLEX MESH DART - 510kdatabase.net

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) K922916 24 fields · synced Oct 1, 2026