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Remanufactured LigaSure Exact Dissector Without Nano-Coating LF2019

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230255

by Stryker Sustainability Solutions

Identifiers

510(k) Number
K230255 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Remanufactured LigaSure Exact Dissector Without Nano-Coating LF2019 is a bipolar electrosurgical device classified under the nomenclature for electrosurgical cutting and coagulation instruments. It is designed for open surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics using controlled electrosurgical energy.

This device is supplied as a remanufactured version, intended for single-use after reprocessing in accordance with regulatory standards. It is regulated under 21 CFR 878.4400 and holds an FDA 510(k) clearance (K230255) as substantially equivalent to its original design. The LF2019 model is part of a reprocessed line of LigaSure devices, adhering to strict quality and safety protocols for surgical reuse.

Frequently asked questions

What is the Remanufactured LigaSure Exact Dissector LF2019 used for?

This device is designed for open surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics. It uses controlled electrosurgical energy to achieve precise dissection, reducing the risk of bleeding during surgery. The LF2019 model is part of a reprocessed line of LigaSure devices, ensuring it meets the same safety and performance standards as its original version.

How is the Remanufactured LigaSure Exact Dissector LF2019 supplied and intended for use?

The device is supplied as a remanufactured version, meaning it undergoes reprocessing to meet regulatory standards for reuse. It is intended for single-use only after reprocessing, adhering to strict quality protocols to ensure safety and efficacy. This aligns with FDA guidelines for remanufactured medical devices under 21 CFR 878.4400.

Is the LF2019 model sterile and how should it be stored?

The device is remanufactured to meet sterility standards required for surgical use. After reprocessing, it should be stored in a clean, dry environment protected from contamination until use. Follow manufacturer guidelines for packaging and storage to maintain sterility and functionality.

What distinguishes the LF2019 from other LigaSure devices?

The LF2019 is a remanufactured version of the LigaSure Exact Dissector without the Nano-coating, which may affect its surface properties. It retains the same core functionality for controlled electrosurgical cutting and coagulation but is part of a reprocessed line, offering a sustainable alternative to single-use devices. The model number ensures compatibility with existing LigaSure systems.

What regulatory approval does the Remanufactured LigaSure Exact Dissector LF2019 hold?

The device holds an FDA 510(k) clearance (K230255) under the Special Review pathway, classified as substantially equivalent to its original design. This clearance confirms it meets regulatory requirements for safety and performance in its intended surgical applications. The approval is specific to this remanufactured version.

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: PDF Increased precision, - Stryker, Reprocessed LigaSure™ vessel sealing device - Stryker, Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019, STRYKER LF2019 INSTRUCTIONS FOR USE MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Sustainability Solutions

Sources (1)

  • FDA 510(k) K230255 24 fields · synced Oct 1, 2026