Neurolac Nerve Guide

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

510(k) Number

K050573 ↗

FDA Product Code

JXI

Device Class

Class II

Regulation

21 CFR Part 882.5275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Nasopore Ear Open recall

  Class II

  FDA 510(k) K070715 Active Cleared 7 May 2007

• Vivosorb Sheet, Model FS01

  Class II

  FDA 510(k) K042811 Active Cleared 8 Nov 2004

• Nasopore Ear, Models ND04, ND05

  Class I

  FDA 510(k) K062540 Active Cleared 18 Oct 2006

• Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

  Class II

  FDA 510(k) K032115 Active Cleared 10 Oct 2003

• Hemopore

  Class I

  FDA 510(k) K141816 Active Cleared 23 Oct 2014

• Neurolac(R) Nerve Guide

  Class II

  FDA 510(k) K112267 Active Cleared 20 Oct 2011

See all devices from Polyganics B.V., →

• What is the Neurolac Nerve Guide intended for?

  The Neurolac Nerve Guide is designed to guide and protect nerves during regeneration from the proximal stump towards the distal stump, preventing neuroma formation and fibrous tissue ingrowth into the nerve gap to support tension-less nerve repair for optimal healing in peripheral nerve applications.

• How is the Neurolac Nerve Guide supplied and what is its sterility status?

  The device is supplied as a sterile, single-use implant by Polyganics B.V., meaning it is provided in a sterile condition and intended for one-time use only during peripheral nerve repair procedures.

• What regulatory pathway was used for the Neurolac Nerve Guide and what is its classification?

  The Neurolac Nerve Guide received FDA 510(k) clearance under K050573 and is classified as a Class II medical device under regulation number 882.5275, based on a determination of substantial equivalence to a predicate device.