Cleared Traditional

K132660 - NERVE CUFF

K132660 is an FDA 510(k) clearance for NERVE CUFF, manufactured by Cook Biotech Incorporated. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K132660 · Cook Biotech Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
137d
Days
Class 2
Risk

K132660 is an FDA 510(k) clearance for the NERVE CUFF. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 137 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 Cook Biotech Incorporated devices

FDA 510(k) Submission Details - K132660

510(k) Number K132660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date January 10, 2014
Days to Decision 137 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
12d faster than avg
Panel avg: 149d · This submission: 137d
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 38
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K132660.
Reaxon Plus
K143711 · Medovent GmbH · Dec 2015
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
K103081 · Biom'Up Sas · Mar 2012
NEUROLAC(R) NERVE GUIDE
K112267 · Polyganics B.V., · Oct 2011
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
K100382 · Salumedica, LLC · Aug 2010