Cleared Traditional

K983007 - NEUROTUBE

K983007 is an FDA 510(k) clearance for NEUROTUBE, manufactured by Neuroregen, LLC. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K983007 · Neuroregen, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
206d
Days
Class 2
Risk

K983007 is an FDA 510(k) clearance for the NEUROTUBE. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Neuroregen, LLC (Bel Air, US). The FDA issued a Cleared decision on March 22, 1999 after a review of 206 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 Neuroregen, LLC devices

FDA 510(k) Submission Details - K983007

510(k) Number K983007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date March 22, 1999
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
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.