Cleared Traditional

K960631 - MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX

K960631 is an FDA 510(k) clearance for MEDTRONIC MODEL 3550 ACCESSORY KIT (CON..., manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K960631 · Medtronic Vascular · Neurology device
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May 1996
Decision
97d
Days
Class 2
Risk

K960631 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 21, 1996 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 882.5870 - 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 - K960631

510(k) Number K960631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1996
Decision Date May 21, 1996
Days to Decision 97 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
51d faster than avg
Panel avg: 148d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZF Device Classification - Class 2, Special Controls

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
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 - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 24
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K960631.
RENEW NEUROSTIMULATION SYSTEM
K000852 · Advanced Neuromodulation Systems · Jan 2001
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105 · Medtronic Vascular · Apr 2000
PERIPHERAL NERVE STIMULATION
K982902 · Medtronic Vascular · Nov 1998
TECOTHANE 55D
K950425 · Medtronic Vascular · Apr 1995
MEDTRONIC MODEL 3990 PNS LEAD
K925952 · Medtronic Vascular · Aug 1993
MODELS 3987 AND 3988 RESUME LEAD FOR PNS
K920567 · Medtronic Vascular · May 1992