Cleared Traditional

K013120 - PERCUTANEOUS INTRODUCER SET

K013120 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER SET, manufactured by Medamicus, Inc.. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K013120 · Medamicus, Inc. · Neurology device
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Jan 2002
Decision
128d
Days
Class 2
Risk

K013120 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 128 days - within the typical 510(k) review window.

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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K013120

510(k) Number K013120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2001
Decision Date January 24, 2002
Days to Decision 128 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
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

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 76
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