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LiquiBand XL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211878

by Advanced Medical Solutions Limited

Identifiers

510(k) Number
K211878 FDA 510(k)
FDA Product Code
OMD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4011 FDA 510(k)
Regulation Number
878.4011 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LiquiBand XL is a Cutaneous Tissue Adhesive With Mesh, classified under FDA regulation 878.4011. This device combines a mesh patch with a liquid adhesive to provide secure closure for large or high-tension surgical incisions, reducing the need for sutures or staples while promoting wound stability.

Intended for use in General and Plastic Surgery, the LiquiBand XL is supplied as a single-use, sterile product. It is designed for in-office or operating room application and remains effective for up to 14 days post-application. The device holds FDA 510(k) clearance (K211878) and is distributed in various sizes and reference codes as listed in the regulatory submission.

Frequently asked questions

What types of surgical incisions is the LiquiBand XL designed to close, and how does it differ from traditional sutures or staples?

The LiquiBand XL is specifically designed for large or high-tension surgical incisions in General and Plastic Surgery, where traditional sutures or staples might be less effective. It combines a mesh patch with a liquid adhesive to provide secure closure, reducing reliance on sutures while promoting wound stability and durability for up to 14 days post-application. This makes it ideal for scenarios where minimizing tissue trauma or achieving faster healing is beneficial.

Is the LiquiBand XL reusable, or is it intended for single-use only? How should it be stored?

The LiquiBand XL is strictly single-use and supplied as a sterile product, ensuring patient safety and hygiene. It should be stored according to manufacturer guidelines—typically in a cool, dry place, protected from direct sunlight and extreme temperatures. Always check the packaging for specific storage instructions to maintain sterility and efficacy.

What sizes or reference codes are available for the LiquiBand XL, and how do I determine the right fit for a patient’s incision?

The LiquiBand XL is available in multiple sizes and reference codes, as listed in the regulatory submission (e.g., FEI numbers like 3010571423, 3004530184, etc.). The correct size depends on the incision length and tension—consult the manufacturer’s sizing guide or clinical documentation to match the wound dimensions. The mesh patch is designed to conform to varying incision sizes while providing secure adhesion.

How long does the LiquiBand XL remain effective after application, and what factors might affect its durability?

The LiquiBand XL is designed to remain effective for up to 14 days post-application, providing stable wound closure during the critical healing period. Durability depends on proper application technique, patient movement, and skin condition. Avoid excessive stress or friction on the site, as this could compromise adhesion. Follow postoperative care instructions to maximize its performance.

What regulatory pathway does the LiquiBand XL follow, and how can I verify its compliance?

The LiquiBand XL follows the FDA 510(k) clearance pathway, classified under regulation 878.4011 as a *Cutaneous Tissue Adhesive With Mesh*. It holds clearance number K211878 and is distributed by Advanced Medical Solutions Limited. To verify compliance, check the device’s registration number (e.g., 1061124) or FEI numbers (e.g., 3010571423) on the FDA’s OpenFDA database or the manufacturer’s documentation. Always ensure the lot or batch code matches the approved submission.

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: Liquiband - Skin Adhesives - Surgical Wound Closure - Choose your …, Large Incision Adhesives - Advanced Medical Solutions, UK Region - LiquiBand® - Surgical Wound Closure - Skin Adhesives, Traditional Topical Skin Adhesives - Advanced Medical Solutions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Medical Solutions Limited

Sources (1)

  • FDA 510(k) K211878 24 fields · synced Oct 6, 2026