Cleared Traditional

K131541 - FLEXIBLE COOAGEN NERVE CUFF

K131541 is the FDA 510(k) clearance for FLEXIBLE COOAGEN NERVE CUFF by Collagen Matrix, Inc.. It is a Class 2 Neurology device (product code JXI) cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K131541 · Collagen Matrix, Inc. · Neurology device
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Apr 2014
Decision
309d
Days
Class 2
Risk

K131541 is an FDA 510(k) clearance for the FLEXIBLE COOAGEN NERVE CUFF. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Collagen Matrix, Inc. devices

Submission Details

510(k) Number K131541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2013
Decision Date April 03, 2014
Days to Decision 309 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 148d · This submission: 309d
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 23
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K131541.
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · 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