Cleared Special

K112267 - NEUROLAC NERVE GUIDE

K112267 is an FDA 510(k) clearance for NEUROLAC NERVE GUIDE, manufactured by Polyganics B.V.,. The device is a Class 2 Neurology device with product code JXI cleared through the Special 510(k) pathway after a 73-day FDA review.

K112267 · Polyganics B.V., · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
73d
Days
Class 2
Risk

K112267 is an FDA 510(k) clearance for the NEUROLAC(R) NERVE GUIDE. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Polyganics B.V., (Groningen, NL). The FDA issued a Cleared decision on October 20, 2011 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Polyganics B.V., devices

FDA 510(k) Submission Details - K112267

510(k) Number K112267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2011
Decision Date October 20, 2011
Days to Decision 73 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

JXI Device Classification - Class 2, Special Controls

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXI Cuff, Nerve

All 27
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K112267.
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
COLLAGEN NERVE WRAP
K060952 · Collagen Matrix, Inc. · Jul 2006
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp. · Jul 2004
SURGISIS NERVE CUFF
K031069 · Cook Biotech, Inc. · May 2003