Cleared Traditional

K010300 - MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EX...

K010300 is the FDA 510(k) clearance for MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EX... by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K010300 · Medtronic Vascular · Neurology device
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Aug 2001
Decision
181d
Days
Class 2
Risk

K010300 is an FDA 510(k) clearance for the MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 181 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K010300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date August 01, 2001
Days to Decision 181 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
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 74
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K010300.
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