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Ligaclip Endo LD Applier/Divider

by Ethicon Inc.

510(k) K920847

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 NumberK920847 Date29 May 1992ClearedStatusActive

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  • Withdrawn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)

Full name
Ethicon Ligaclip Endo Ld Applier/Divider
510(k) Number
FDA Product Code
FZP
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4300
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 Ligaclip Endo LD Applier/Divider is a surgical device classified as a Clip, Implantable (Product Code: FZP), designed for endoscopic ligation of vessels or tissue. It applies metallic clips to occlude tubular structures, such as blood vessels or fallopian tubes, during minimally invasive procedures. The device is intended for use in general and plastic surgery applications, providing a means to secure tissue without sutures or knots.

This device is supplied as a reusable applicator/divider system, intended for single-use per procedure before sterilization. It is not MRI-safe and must be used in non-MRI environments. The Ligaclip Endo LD Applier/Divider was granted FDA 510(k) clearance (K920847) under the Traditional 510(k) review pathway, classified as Class II with Special Controls. It is regulated under the Federal Food, Drug, and Cosmetic Act (Regulation Number: 878.4300) and is manufactured by Ethicon Inc., Cincinnati, OH.

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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 Ligaclip Endo LD Applier/Divider used for?

    The Ligaclip Endo LD Applier/Divider is designed for endoscopic ligation of vessels or tissue, such as blood vessels or fallopian tubes. It applies metallic clips to occlude tubular structures during minimally invasive procedures, providing a suture-free method to secure tissue in general and plastic surgery applications.

  • Is the Ligaclip Endo LD Applier/Divider reusable or single-use?

    The Ligaclip Endo LD Applier/Divider is supplied as a reusable applicator/divider system. It is intended for single-use per procedure before sterilization, meaning it can be cleaned and reused after each application, provided proper sterilization protocols are followed.

  • Can the Ligaclip Endo LD Applier/Divider be used in MRI environments?

    No, the Ligaclip Endo LD Applier/Divider is not MRI-safe. It must be used exclusively in non-MRI environments to avoid interference or safety risks.

  • What regulatory pathway was followed for the Ligaclip Endo LD Applier/Divider?

    The Ligaclip Endo LD Applier/Divider was granted FDA 510(k) clearance under the Traditional 510(k) review pathway. It is classified as Class II with Special Controls and is regulated under the Federal Food, Drug, and Cosmetic Act (Regulation Number: 878.4300).

  • What surgical specialties commonly use the Ligaclip Endo LD Applier/Divider?

    The Ligaclip Endo LD Applier/Divider is primarily used in general and plastic surgery applications. It is intended for endoscopic procedures where vessel or tissue ligation is required, offering a reliable alternative to sutures or knots.