Cleared Traditional

K921558 - MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS

K921558 is an FDA 510(k) clearance for MEDTRONIC MODELS 3983A AND 3983B RESUME..., 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 97-day FDA review.

K921558 · Medtronic Vascular · Neurology device
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Jul 1992
Decision
97d
Days
Class 2
Risk

K921558 is an FDA 510(k) clearance for the MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS. 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 July 7, 1992 after a review of 97 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 - K921558

510(k) Number K921558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date July 07, 1992
Days to Decision 97 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
51d faster than avg
Panel avg: 148d · This submission: 97d
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 K921558.
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931 · Medtronic Vascular · Mar 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522 · Medtronic Vascular · Mar 1993
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
K923567 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
K913993 · Medtronic Vascular · Feb 1992
MEDTRONIC MODEL 3586 RESUME LEAD
K913934 · Medtronic Vascular · Jan 1992
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433 · Medtronic Vascular · Dec 1991