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Barle Tissue Adhesive

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123133

by Advanced Medical Solutions (Plymouth), Ltd.

Identifiers

510(k) Number
K123133 FDA 510(k)
FDA Product Code
MPN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4010 FDA 510(k)
Regulation Number
878.4010 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Barle Tissue Adhesive is a Tissue Adhesive for the Topical Approximation of Skin, designed to promote wound closure by bonding easily approximated skin edges. It is intended for use in surgical incisions, minimally invasive surgery punctures, and clean, thoroughly cleansed trauma-induced lacerations. This adhesive provides a secure, cohesive seal to facilitate healing while maintaining a sterile environment.

Supplied as a sterile, single-use product, the Barle Tissue Adhesive is regulated under FDA 510(k) clearance (K123133) and classified as a Class II medical device (regulation number 878.4010). It is intended for topical application only and must be used in accordance with surgical or trauma wound management protocols. Storage conditions are not specified in the regulatory data, but standard sterile medical device storage practices should be followed.

Frequently asked questions

What is the Barle Tissue Adhesive used for?

The Barle Tissue Adhesive is designed for the topical approximation of skin, specifically to bond easily approximated skin edges in surgical incisions, minimally invasive surgery punctures, and clean, thoroughly cleansed trauma-induced lacerations. It facilitates wound closure by creating a secure, cohesive seal, which helps promote healing while maintaining a sterile environment.

Is the Barle Tissue Adhesive sterile and single-use?

Yes, the Barle Tissue Adhesive is supplied as a sterile, single-use product. This ensures that each application is free from contamination, adhering to best practices for wound management and infection control.

How should the Barle Tissue Adhesive be stored?

While specific storage conditions are not detailed in the regulatory data, standard sterile medical device storage practices should be followed. This typically includes keeping the adhesive in a clean, dry environment, protected from direct light and extreme temperatures, to preserve its integrity and sterility.

Is the Barle Tissue Adhesive reusable?

No, the Barle Tissue Adhesive is intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining the adhesive’s effectiveness for one application.

What regulatory approval does the Barle Tissue Adhesive hold?

The Barle Tissue Adhesive is regulated under FDA 510(k) clearance with the clearance number K123133. It is classified as a Class II medical device under regulation number 878.4010, indicating it has undergone evaluation to ensure its safety and effectiveness for its intended use.

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: K132243 FDA 510 (k) - BARLE TISSUE ADHESIVE 2, K123133 FDA 510 (k) - BARLE TISSUE ADHESIVE, BARLE TISSUE ADHESIVE (K123133) — FDA 510 (k) | Innolitics, BARLE TISSUE ADHESIVE 510(k) K123133 - FDA.report, Contact - Advanced Medical Solutions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Medical Solutions (Plymouth), Ltd.

Sources (1)

  • FDA 510(k) K123133 24 fields · synced Oct 1, 2026