Cleared Traditional

K913442 - MEDTRONIC 3625 SCREENER SYSTEM

K913442 is an FDA 510(k) clearance for MEDTRONIC 3625 SCREENER SYSTEM, 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 112-day FDA review.

K913442 · Medtronic Vascular · Neurology device
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Nov 1991
Decision
112d
Days
Class 2
Risk

K913442 is an FDA 510(k) clearance for the MEDTRONIC 3625 SCREENER SYSTEM. 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 November 22, 1991 after a review of 112 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 - K913442

510(k) Number K913442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1991
Decision Date November 22, 1991
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
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 K913442.
MEDTRONIC MODEL 3586 RESUME LEAD
K913934 · Medtronic Vascular · Jan 1992
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · Medtronic Vascular · Dec 1991
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K912764 · Medtronic Vascular · Nov 1991
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
K905569 · Biomedical Life Systems, Inc. · Jun 1991
MEDTRONIC (R) MODEL 3625 SCREENER
K903690 · Medtronic Vascular · Feb 1991
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K910199 · Medtronic Vascular · Feb 1991