Cleared Traditional

K060952 - COLLAGEN NERVE WRAP

K060952 is an FDA 510(k) clearance for COLLAGEN NERVE WRAP, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K060952 · Collagen Matrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
99d
Days
Class 2
Risk

K060952 is an FDA 510(k) clearance for the COLLAGEN NERVE WRAP. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on July 14, 2006 after a review of 99 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 Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K060952

510(k) Number K060952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date July 14, 2006
Days to Decision 99 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
49d faster than avg
Panel avg: 148d · This submission: 99d
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 35
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K060952.
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
NERVE CUFF
K132660 · Cook Biotech Incorporated · Jan 2014
NEUROLAC(R) NERVE GUIDE
K112267 · Polyganics B.V., · Oct 2011
NEUROLAC NERVE GUIDE
K050573 · Polyganics B.V., · May 2005
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp. · Jul 2004
SURGISIS NERVE CUFF
K031069 · Cook Biotech, Inc. · May 2003