Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain Relief

Q: What is the product code of K011584?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.

FDA 510(k) K011584 · Medtronic Vascular

Substantially Equivalent

510(k) numberK011584

Submission

Device name: Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain Relief
Applicant: Medtronic Vascular
Minneapolis, MN, US
Received: May 23, 2001
Decision date: June 22, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5880
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code GZB

510(k)	Device	Applicant	Decision
K233801	Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional	Boston Scientific Neuromodulation	08/23/2024SE
K221376	Nalu Neurostimulation SystemGZB · Special	Boston Scientific Neuromodulation	06/10/2022SE
K203547	Nalu Neurostimulation SystemGZB · Traditional	Boston Scientific Neuromodulation	03/25/2021SE
K202274	Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional	Boston Scientific Neuromodulation	11/09/2020SE
K201618	Nalu Neurostimulation SCS systemGZB · Special	Boston Scientific Neuromodulation	07/15/2020SE
K191466	SandShark Injectable Anchor (SIA) SystemGZB · Traditional	Stimwave Technologies, Inc.	11/07/2019SE
K190960	Nalu Lead Blank (50cm)GZB · Traditional	Boston Scientific Neuromodulation	07/11/2019SE
K182720	Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional	Stimwave Technologies Incorporated	03/29/2019SE
K183047	Nalu Neurostimulation SystemGZB · Traditional	Boston Scientific Neuromodulation	03/22/2019SE
K180981	Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional	Stimwave Technologies Incorporated	09/19/2018SE

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K192296	Medtronic 6F Taiga Guiding CatheterDQY · Special	09/20/2019SE
K182957	Heli-FX EndoAnchor SystemOTD · Special	11/21/2018SE
K173515	Admiral XtremeLIT · Traditional	04/12/2018SE
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Questions and answers

When was Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain Relief cleared by the FDA?

Medtronic Spinal Cord Stimulation and Peripheral Nerve Stimulation Systems for Pain Relief (K011584) received a 510(k) decision of Substantially Equivalent on June 22, 2001, 30 days after the submission was received.

What is the product code of K011584?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.