Cleared Traditional

K994097 - MEDAMICUS EPIDURAL INTRODUCER

K994097 is an FDA 510(k) clearance for MEDAMICUS EPIDURAL INTRODUCER, 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 89-day FDA review.

K994097 · Medamicus, Inc. · Neurology device
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Mar 2000
Decision
89d
Days
Class 2
Risk

K994097 is an FDA 510(k) clearance for the MEDAMICUS EPIDURAL INTRODUCER. 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 March 1, 2000 after a review of 89 days - a notably fast clearance 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: 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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K994097

510(k) Number K994097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date March 01, 2000
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K994097.
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · Medtronic Vascular · Aug 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
K011584 · Medtronic Vascular · Jun 2001
MEDTRONIC MODEL 7499 EXTENSION
K000445 · Medtronic Vascular · Apr 2000
MEDTRONIC MODEL 7495 EXTENSION KIT
K990104 · Medtronic Vascular · Feb 1999
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K972906 · Medtronic Vascular · Feb 1998
MEDTRONIC MODEL 3998 LEAD
K971756 · Medtronic Vascular · Feb 1998