Cleared Traditional

K971756 - MEDTRONIC MODEL 3998 LEAD

K971756 is an FDA 510(k) clearance for MEDTRONIC MODEL 3998 LEAD, 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 267-day FDA review.

K971756 · Medtronic Vascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
267d
Days
Class 2
Risk

K971756 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3998 LEAD. 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 3, 1998 after a review of 267 days - an extended review 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: 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 - K971756

510(k) Number K971756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date February 03, 1998
Days to Decision 267 days
Submission Type Traditional
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
119d slower than avg
Panel avg: 148d · This submission: 267d
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 K971756.
LAMITRODE LEADS
K990469 · Advanced Neuromodulation Systems · Jun 1999
MEDTRONIC MODEL 7495 EXTENSION KIT
K990104 · Medtronic Vascular · Feb 1999
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K972906 · Medtronic Vascular · Feb 1998
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · Medtronic Vascular · Aug 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
K964172 · Medtronic Vascular · Jul 1997
BIFURCATED Y-EXTENSION
K953742 · Medtronic Vascular · Nov 1996