Cleared Traditional

K050573 - NEUROLAC NERVE GUIDE

K050573 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 Traditional 510(k) pathway after a 58-day FDA review.

K050573 · Polyganics B.V., · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
58d
Days
Class 2
Risk

K050573 is an FDA 510(k) clearance for the NEUROLAC 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 May 4, 2005 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polyganics B.V., devices

FDA 510(k) Submission Details - K050573

510(k) Number K050573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date May 04, 2005
Days to Decision 58 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 148d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050573.
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
COLLAGEN NERVE CUFF
K012814 · Collagen Matrix, Inc. · Sep 2001