MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel)
FDA 510(k) K862915 · Neuromed, Inc.
510(k) numberK862915
Submission
- Device name
- MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel)
- Applicant
- Neuromed, Inc.
Davies, FL, US - Received
- August 1, 1986
- Decision date
- October 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GZB
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|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | Boston Scientific Neuromodulation | 08/23/2024SE |
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| 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 |
More from Stimwave Technologies Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode)GZB · Traditional | 05/22/1996SE |
| K930536 | Neuromed Octrode Model MNR-88A-B-C Neurostim RecGZB · Traditional | 12/15/1994SE |
| K930498 | Neuromed Octrode Model MNT-98 Neurostimulator TranGZB · Traditional | 12/12/1994SE |
| K930242 | Introde INT-8GZB · Traditional | 02/02/1994SE |
| K921319 | Neuromed Model OCA-30 Octode and Model SCA-30GZB · Traditional | 05/05/1993SE |
| K905596 | Neuromed Octrode Model MNR-88B/88C Neurostim SystGZB · Traditional | 03/11/1991SE |
| K905255 | Neuromed Model 1992 LS Lamitrode LeadGZB · Traditional | 01/25/1991SE |
| K903814 | Neuromed TS8 Test StimulatorGZB · Traditional | 01/16/1991SE |
| K901499 | Neuromed Octrode Model MNR-88 W/98 Adapter Neuro.GZB · Traditional | 06/29/1990SE |
| K860185 | Unistim UNT-1M Neurostimulator TransmitterGZB · Traditional | 04/04/1986SE |
Questions and answers
When was MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel) cleared by the FDA?
MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel) (K862915) received a 510(k) decision of Substantially Equivalent on October 6, 1986, 66 days after the submission was received.
What is the product code of K862915?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.