Cleared Traditional

K032115 - NEUROLAC NERVE GUIDE MODELS NG01-15/03

K032115 is an FDA 510(k) clearance for NEUROLAC NERVE GUIDE MODELS NG01-15/03, 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 93-day FDA review.

K032115 · Polyganics B.V., · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
93d
Days
Class 2
Risk

K032115 is an FDA 510(k) clearance for the NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03. 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 10, 2003 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Polyganics B.V., devices

FDA 510(k) Submission Details - K032115

510(k) Number K032115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date October 10, 2003
Days to Decision 93 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
55d faster than avg
Panel avg: 148d · This submission: 93d
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 K032115.
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
NEUROGEN NERVE GUIDE
K011168 · Integra Lifesciences Corp. · Jun 2001