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Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

by Surgical Instrument Service and Savings, Inc.

510(k) K160333

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160333 Date20 Jul 2016ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0471-2026 FDA Class II initiated 1 Oct 2025
    • Ongoing Z-0474-2026 FDA Class II initiated 1 Oct 2025
    • Ongoing Z-0473-2026 FDA Class II initiated 1 Oct 2025
    • Ongoing Z-0472-2026 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.

    • Ongoing Z-3092-2024 FDA Class II initiated 7 May 2024

    Potential for an incomplete seal on the packaging tray.

    • Ongoing Z-0117-2024 FDA Class II initiated 3 Aug 2023

    Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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, 28 Sep 2026

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

The Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider is a bipolar electrosurgical accessory classified as a Class II device. It provides sealing and division of vessels, tissue bundles, and lymphatics in minimally invasive or open surgical procedures, employing LigaSure vessel‑sealing technology with a blunt tip for open applications.

The instrument is supplied as a reprocessed, open‑tip sealer/divider and is part of Medline’s ReNewal Reprocessing Program. It is cleared under FDA 510(k) (K160333) with product code NUJ and is indicated for vessels up to 7 mm in diameter. The device is intended for use in general and plastic surgery settings and is provided sterile for single‑use after reprocessing.

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Questions

AI-generated answers, 28 Sep 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 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider used for?

    This device is a bipolar electrosurgical accessory designed for sealing and division of vessels, tissue bundles, and lymphatics in minimally invasive or open surgical procedures. It is specifically intended for use in general and plastic surgery settings.

  • How is the Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider supplied?

    The instrument is supplied as a reprocessed, open-tip sealer/divider as part of Medline's ReNewal Reprocessing Program. It is provided sterile for single-use after reprocessing, ensuring safety and effectiveness for each surgical procedure.

  • What vessel sizes can the Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider handle?

    This device is indicated for vessels up to 7mm in diameter, making it suitable for a wide range of surgical applications where vessel sealing and division are required in general and plastic surgery procedures.

  • Is the Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider reusable?

    No, this device is designed for single-use after reprocessing. While it undergoes Medline's reprocessing program, it is intended to be used once and then discarded to maintain sterility and performance standards.