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Liquiband Ultima Lut 003

by Medlogic Global Limited

510(k) K100284

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100284 Date9 Apr 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
MPN
Device Class
Class II
Regulation
21 CFR Part 878.4010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

Liquiband Ultima Lut 003 is a tissue adhesive for the topical approximation of skin. It is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges.

The device is supplied in a single patient use dual tip configuration. It is classified as a Class II medical device under FDA regulation number 878.4010 and received 510(k) clearance (K100284) on April 9, 2010, based on substantial equivalence to a predicate device.

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Questions

AI-generated answers, 21 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 LIQUIBAND ULTIMA LUT 003 used for?

    LIQUIBAND ULTIMA LUT 003 is indicated for the topical approximation of skin, specifically for closing topical skin incisions such as laparoscopic incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges.

  • How is LIQUIBAND ULTIMA LUT 003 supplied and is it reusable?

    The device is supplied in a single patient use dual tip configuration, meaning it is intended for one-time use on one patient and should not be reused due to infection risk and loss of adhesive integrity after application.

  • What regulatory pathway was used for LIQUIBAND ULTIMA LUT 003 and when was it cleared?

    LIQUIBAND ULTIMA LUT 003 received FDA 510(k) clearance (K100284) on April 9, 2010, based on substantial equivalence to a predicate device, and is classified as a Class II medical device under FDA regulation number 878.4010.