Medtronic Clip Gun Kit

• • Terminated Z-3212-2018 FDA Class II ·initiated 3 May 2018

  The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

• • Terminated Z-0622-2018 FDA Class II ·initiated 20 Dec 2017

  Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

510(k) Number

K050044 ↗

FDA Product Code

HBO

Device Class

Class II

Regulation

21 CFR Part 882.4150

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Neurosurgery →

• What is the primary function of the Medtronic Clip Gun Kit?

  This manual surgical instrument is designed to apply Raney-type scalp clips during craniotomy procedures. It functions by clamping small vessels of the skin and deeper vessels under the scalp to effectively provide hemostasis and prevent arterial bleeding.

• What is the regulatory status of this device?

  The Medtronic Clip Gun Kit has received FDA 510(k) clearance under K050044. It is classified as a Class 2 device under regulation number 882.4150, which pertains to scalp clips used in neurosurgical procedures.

• Which medical specialty is this device intended for?

  The device is intended for use within the field of neurology. It is specifically designed to assist surgeons during craniotomy procedures by managing bleeding through the application of specialized scalp clips.