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Medtronic Model 3550 Accessory Kit (Contents) 3550-OX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960631

by Medtronic Vascular

Identifiers

510(k) Number
K960631 FDA 510(k)
FDA Product Code
GZF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5870 FDA 510(k)
Regulation Number
882.5870 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Stimulator, Peripheral Nerve, Implanted (Pain Relief) accessory kit, as defined by its FDA classification and product code GZF. It is intended for use with spinal cord and peripheral nerve stimulation leads to facilitate lead placement or connection during clinical procedures.

The kit is supplied in nonsterile packaging and intended for user-performed sterilization, with labeling that includes sterilization instructions. It is provided as kits, piece parts, or bulk and used by clinicians in surgical or clinical settings. The device received FDA 510(k) clearance (K960631) in 1996 as a Class II device under regulation number 882.5870, with special controls, and is manufactured by Medtronic Vascular in Minneapolis, MN.

Frequently asked questions

What is the Medtronic Model 3550 Accessory Kit 3550-OX used for?

The kit is intended for use with spinal cord and peripheral nerve stimulation leads to facilitate lead placement or connection during clinical procedures. It supports the implantation and setup of peripheral nerve stimulators for pain relief by providing necessary components for lead handling and connection.

How is the Medtronic Model 3550 Accessory Kit 3550-OX supplied and prepared for use?

The kit is supplied in nonsterile packaging and is intended for user-performed sterilization. Labeling includes sterilization instructions, and it is provided as kits, piece parts, or bulk for clinicians to prepare according to their facility's protocols before use in surgical or clinical settings.

Is the Medtronic Model 3550 Accessory Kit 3550-OX reusable or single-use?

The device data does not specify whether the kit is reusable or single-use. It is supplied nonsterile for user-performed sterilization, which suggests it may be designed for reuse after proper sterilization, but reuse instructions or limits are not provided in the available information.

What regulatory pathway was used for the Medtronic Model 3550 Accessory Kit 3550-OX?

The device received FDA 510(k) clearance (K960631) in 1996 as a Class II device under regulation number 882.5870. It was found substantially equivalent to a predicate device and is subject to special controls, with product code GZF and classification under Neurology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medtronic Model 3550 Accessory Kit (Contents) 3550-ox (K960631) — Fda ..., K960631 FDA 510(k) - MEDTRONIC MODEL 3550 ACCESSORY KIT (CON..., MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX by MEDTRONIC ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K960631 24 fields · synced Oct 6, 2026