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Perneczky Clip Applier/Remover

by Von Zeppelin GmbH 510(k)

Active United States

510(k) K954658

Overview

The Perneczky Clip Applier/Remover is a neurosurgical device used for applying and removing aneurysm clips. It is designed for use in neurology procedures to manage cerebral aneurysms. The device is part of the Perneczky Aneurysm Clip system and is intended for use by trained medical professionals.

The Perneczky Clip Applier/Remover is supplied as a reusable device and is MRI safe up to 3 Tesla. It is manufactured by Von Zeppelin GmbH and has FDA 510(k) clearance with product code HCI. The device is available in various models and sizes as specified by the manufacturer.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954658 Date8 Oct 1996ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HCI
Device Class
Class II
Regulation
21 CFR Part 882.4175
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Von Zeppelin GmbH

Questions

  • What is the Perneczky Clip Applier/Remover used for?

    The Perneczky Clip Applier/Remover is a neurosurgical device specifically designed for applying and removing aneurysm clips during neurology procedures to manage cerebral aneurysms. It is intended for use by trained medical professionals.

  • Is the Perneczky Clip Applier/Remover a single-use or reusable device?

    The Perneczky Clip Applier/Remover is supplied as a reusable device. It is designed for multiple uses in clinical settings, though proper sterilization and maintenance protocols should be followed according to manufacturer instructions.

  • What models and sizes are available for the Perneczky Clip Applier/Remover?

    The device is available in various models and sizes as specified by the manufacturer, Von Zeppelin GmbH. The specific models and sizes would be detailed in the product documentation provided with the device.

  • What is the regulatory status of the Perneczky Clip Applier/Remover?

    The Perneczky Clip Applier/Remover has FDA 510(k) clearance with product code HCI. It is classified as a Class II device and has been determined to be substantially equivalent to predicate devices for neurology procedures.