Cleared Traditional

K100382 - SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

K100382 is an FDA 510(k) clearance for SALUTUNNEL NERVE PROTECTOR, manufactured by Salumedica, LLC. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K100382 · Salumedica, LLC · Neurology device
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Aug 2010
Decision
170d
Days
Class 2
Risk

K100382 is an FDA 510(k) clearance for the SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Salumedica, LLC (Atlanta, US). The FDA issued a Cleared decision on August 5, 2010 after a review of 170 days - an extended review 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: 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 Salumedica, LLC devices

FDA 510(k) Submission Details - K100382

510(k) Number K100382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date August 05, 2010
Days to Decision 170 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
22d slower than avg
Panel avg: 148d · This submission: 170d
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 29
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K100382.
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · Collagen Matrix, Inc. · Apr 2014
NERVE CUFF
K132660 · Cook Biotech Incorporated · Jan 2014
COLLAGEN NERVE WRAP
K060952 · Collagen Matrix, Inc. · Jul 2006
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp. · Jul 2004
SURGISIS NERVE CUFF
K031069 · Cook Biotech, Inc. · May 2003