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Medline ReNewal Reprocessed Ligasure Curved Small Jaw Open Sealer/Divider

by Surgical Instrument Services and Savings, Inc.

510(k) K162751

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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162751 Date1 May 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0470-2026 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  • Withdrawn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)

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, 25 Sep 2026

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

This device is an electrosurgical, cutting & coagulation accessory, laparoscopic & endoscopic, reprocessed. It is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

It can be used on vessels (arteries and veins) up to and including 7 mm. The device is supplied as a reprocessed single-use instrument. It is authorized under FDA 510(k) clearance K162751 and classified as a Class II device.

Other devices from Surgical Instrument Services and Savings, Inc.

Questions

AI-generated answers, 25 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 Curved, Small Jaw Open Sealer/Divider used for?

    It is an electrosurgical cutting and coagulation accessory intended for open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired, specifically for vessels up to and including 7 mm in diameter.

  • How is the Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider supplied and is it reusable?

    The device is supplied as a reprocessed single-use instrument, meaning it has been cleaned, inspected, tested, and repackaged for one-time use only after original use, and should not be reused.

  • What regulatory authorization does the Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider have?

    It is authorized under FDA 510(k) clearance K162751 and is classified as a Class II medical device, determined to be substantially equivalent to a legally marketed predicate device.