Cleared Special

K990104 - MEDTRONIC MODEL 7495 EXTENSION KIT

K990104 is an FDA 510(k) clearance for MEDTRONIC MODEL 7495 EXTENSION KIT, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 28-day FDA review.

K990104 · Medtronic Vascular · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
28d
Days
Class 2
Risk

K990104 is an FDA 510(k) clearance for the MEDTRONIC MODEL 7495 EXTENSION KIT. 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 February 9, 1999 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990104

510(k) Number K990104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1999
Decision Date February 09, 1999
Days to Decision 28 days
Submission Type Special
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
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 138
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K990104.
RENEW RECEIVER
K992946 · Advanced Neuromodulation Systems · Sep 1999
RENEW LEAD EXTENSION
K991784 · Advanced Neuromodulation Systems · Jun 1999
LAMITRODE LEADS
K990469 · Advanced Neuromodulation Systems · Jun 1999
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K972906 · Medtronic Vascular · Feb 1998
MEDTRONIC MODEL 3998 LEAD
K971756 · Medtronic Vascular · Feb 1998
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · Medtronic Vascular · Aug 1997
K990104 · MEDTRONIC MODEL 7495 EXTENSION KIT
Download PDF FDA Summary Medtronic Vascular