Cleared Traditional

K960631 - MEDTRONIC MODEL 3550 ACCESSORY KIT (CON...

K960631 is the FDA 510(k) clearance for MEDTRONIC MODEL 3550 ACCESSORY KIT (CON... by Medtronic Vascular. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 19
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K960631.
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
K183579 · Boston Scientific Neuromodulation · Mar 2019
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