Cleared Traditional

K041620 - NEURA WRAP NERVE PROTECTOR

K041620 is the FDA 510(k) clearance for NEURA WRAP NERVE PROTECTOR by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code JXI) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K041620 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
30d
Days
Class 2
Risk

K041620 is an FDA 510(k) clearance for the NEURA WRAP NERVE PROTECTOR. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on July 16, 2004 after a review of 30 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 Integra Lifesciences Corp. devices

Submission Details

510(k) Number K041620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date July 16, 2004
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K041620.
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
COLLAGEN NERVE CUFF
K012814 · Collagen Matrix, Inc. · Sep 2001
FASTUBE NERVE REGENERATION DEVICE
K850785 · Research Medical, Inc. · Jul 1985