Cleared Traditional

K031069 - SURGISIS NERVE CUFF

K031069 is the FDA 510(k) clearance for SURGISIS NERVE CUFF by Cook Biotech, Inc.. It is a Class 2 Neurology device (product code JXI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K031069 · Cook Biotech, Inc. · Neurology device
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May 2003
Decision
41d
Days
Class 2
Risk

K031069 is an FDA 510(k) clearance for the SURGISIS NERVE CUFF. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on May 15, 2003 after a review of 41 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 Cook Biotech, Inc. devices

Submission Details

510(k) Number K031069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date May 15, 2003
Days to Decision 41 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
107d faster than avg
Panel avg: 148d · This submission: 41d
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 K031069.
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