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ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

by Surgical Instrument Service and Savings, Inc.

510(k) K232511

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232511 Date29 Apr 2024ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0467-2026 FDA Class II initiated 1 Oct 2025

    Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
510(k) Number
FDA Product Code
NUJ
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) is a reprocessed electrosurgical cutting and coagulation accessory designed for laparoscopic and endoscopic procedures. It functions as a bipolar electrosurgical instrument, enabling precise dissection, vessel ligation, and tissue sealing through controlled energy delivery. Suitable for use on vessels up to 7 mm in diameter, it is intended for general and plastic surgery applications, including urologic procedures.

This device is supplied as a reprocessed single-use item and is classified under FDA product code NUJ, falling within Class II medical devices for general and plastic surgery. It is cleared for use in sterile surgical settings and adheres to FDA 510(k) regulations, with an authorization date of April 29, 2024. The nano-coated surface enhances performance and durability, ensuring compliance with regulatory standards for reprocessed electrosurgical accessories.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ReNewal Reprocessed LigaSure Exact Dissector Nano-coated (LF2019) used for?

    This device is a reprocessed electrosurgical accessory designed for laparoscopic and endoscopic procedures. It delivers controlled bipolar energy to enable precise dissection, vessel ligation (up to 7mm diameter), and tissue sealing. It is intended for general and plastic surgery applications, including urologic procedures, where accurate cutting and coagulation are required.

  • Is the ReNewal Reprocessed LigaSure Exact Dissector Nano-coated (LF2019) single-use or reusable?

    The device is supplied as a reprocessed single-use item. It undergoes a reprocessing cycle to ensure sterility and safety for clinical use, adhering to FDA regulations for reprocessed electrosurgical accessories. This reprocessing allows for multiple uses while maintaining performance and sterility standards.

  • What does the nano-coated surface on this device provide?

    The nano-coated surface enhances the performance and durability of the ReNewal Reprocessed LigaSure Exact Dissector (LF2019). This coating helps reduce wear during use, improves energy efficiency, and ensures consistent functionality over multiple reprocessing cycles, contributing to reliable surgical outcomes.

  • How is the ReNewal Reprocessed LigaSure Exact Dissector Nano-coated (LF2019) regulated?

    The device is cleared under the FDA’s 510(k) pathway, specifically classified under product code NUJ for general and plastic surgery. It is deemed substantially equivalent to a predicate device and adheres to FDA regulations for reprocessed electrosurgical accessories, ensuring compliance with safety and performance standards.

  • What surgical settings is this device intended for?

    The ReNewal Reprocessed LigaSure Exact Dissector Nano-coated (LF2019) is intended for use in sterile surgical settings, including laparoscopic and endoscopic procedures. Its design and reprocessing ensure it meets regulatory standards for sterile surgical environments, making it suitable for controlled clinical applications.