Cleared Traditional

K940416 - NEUROLOGICAL LEADS (PACKAGING MODIFICATION)

K940416 is an FDA 510(k) clearance for NEUROLOGICAL LEADS (PACKAGING MODIFICATION), 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 171-day FDA review.

K940416 · Medtronic Vascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
171d
Days
Class 2
Risk

K940416 is an FDA 510(k) clearance for the NEUROLOGICAL LEADS (PACKAGING MODIFICATION). 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 18, 1994 after a review of 171 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 - K940416

510(k) Number K940416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1994
Decision Date July 18, 1994
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
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 K940416.
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K934065 · Medtronic Vascular · Feb 1995
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K950127 · Medtronic Vascular · Jan 1995
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K945103 · Medtronic Vascular · Jan 1995
NEUROLOGICAL LEAD ACCESSORIES
K936099 · Medtronic Vascular · Jul 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938 · Medtronic Vascular · Jun 1994
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K932202 · Medtronic Vascular · May 1994