Programmable Spinal Coral Stim. System

FDA 510(k) K810182 · Electronic Diagnostics, Inc.

Substantially Equivalent

510(k) numberK810182

Submission

Device name
Programmable Spinal Coral Stim. System
Applicant
Electronic Diagnostics, Inc.
Mchenry, IL, US
Received
January 22, 1981
Decision date
April 3, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Programmable Spinal Coral Stim. System cleared by the FDA?

Programmable Spinal Coral Stim. System (K810182) received a 510(k) decision of Substantially Equivalent on April 3, 1981, 71 days after the submission was received.

What is the product code of K810182?

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