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Twister Superelastic Ligating Clip and Applier

by Neurosel (Medical) Limited

510(k) K032238

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 NumberK032238 Date9 Sep 2003ClearedStatusActive

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  • Withdrawn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
FZP
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Twister Superelastic Ligating Clip and Applier is an implantable clip device intended for the permanent occlusion or ligation of blood vessels and other tubular body structures. It is designed for use wherever a metal ligating clip is indicated and within the size range of 2.0 to 3.5mm diameter.

The device is supplied as a system comprising the clip and its applier. It received FDA 510(k) clearance (K032238) on September 9, 2003, and is classified as a Class II device under regulation number 878.4300. The device is intended for single-use application in general and plastic surgery settings.

Questions

AI-generated answers, 24 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 Twister Superelastic Ligating Clip and Applier used for?

    The device is intended for the permanent occlusion or ligation of blood vessels and other tubular body structures, designed for use wherever a metal ligating clip is indicated within the 2.0 to 3.5mm diameter range.

  • How is the Twister Superelastic Ligating Clip and Applier supplied and is it reusable?

    The device is supplied as a system comprising the clip and its applier, and is intended for single-use application only, meaning it should not be reused after initial deployment.

  • What regulatory pathway was used for the Twister Superelastic Ligating Clip and Applier?

    The device received FDA 510(k) clearance (K032238) on September 9, 2003, and is classified as a Class II device under regulation number 878.4300.