Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80XX, 81XX, and 82XX

FDA 510(k) K010008 · Micronet Medical, Inc.

Substantially Equivalent

510(k) numberK010008

Submission

Device name
Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80XX, 81XX, and 82XX
Applicant
Micronet Medical, Inc.
White Bear Lake,, MN, US
Received
January 2, 2001
Decision date
July 16, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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)DeviceApplicantDecision
K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional Boston Scientific Neuromodulation08/23/2024SE
K221376Nalu Neurostimulation SystemGZB · Special Boston Scientific Neuromodulation06/10/2022SE
K203547Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/25/2021SE
K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional Boston Scientific Neuromodulation11/09/2020SE
K201618Nalu Neurostimulation SCS systemGZB · Special Boston Scientific Neuromodulation07/15/2020SE
K191466SandShark Injectable Anchor (SIA) SystemGZB · Traditional Stimwave Technologies, Inc.11/07/2019SE
K190960Nalu Lead Blank (50cm)GZB · Traditional Boston Scientific Neuromodulation07/11/2019SE
K182720Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional Stimwave Technologies Incorporated03/29/2019SE
K183047Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/22/2019SE
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional Stimwave Technologies Incorporated09/19/2018SE

Questions and answers

When was Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80XX, 81XX, and 82XX cleared by the FDA?

Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80XX, 81XX, and 82XX (K010008) received a 510(k) decision of Substantially Equivalent on July 16, 2001, 195 days after the submission was received.

What is the product code of K010008?

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