Cleared Traditional

K892884 - MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION

K892884 is an FDA 510(k) clearance for MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K892884 · Medtronic Vascular · Neurology device
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Aug 1989
Decision
110d
Days
Class 2
Risk

K892884 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3530 PERCUTANEOUS 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 7, 1989 after a review of 110 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K892884

510(k) Number K892884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1989
Decision Date August 07, 1989
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
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 117
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K892884.
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K910199 · Medtronic Vascular · Feb 1991
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
K905407 · Medtronic Vascular · Feb 1991
MODEL 3586 RESUME LEAD
K890061 · Medtronic Vascular · Apr 1990
MODEL 3587A RESUME EPIDURAL LEAD
K884948 · Medtronic Vascular · Jan 1989
MODEL 3487A PISCES EPIDURAL LEAD
K885033 · Medtronic Vascular · Jan 1989
XTREL, MODEL NUMBER 3425
K883780 · Medtronic Vascular · Nov 1988