Medtronic (R) Model 3625 Screener
FDA 510(k) K903690 · Medtronic Vascular
510(k) numberK903690
Submission
- Device name
- Medtronic (R) Model 3625 Screener
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- August 15, 1990
- Decision date
- February 14, 1991
- 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 |
| 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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Questions and answers
When was Medtronic (R) Model 3625 Screener cleared by the FDA?
Medtronic (R) Model 3625 Screener (K903690) received a 510(k) decision of Substantially Equivalent on February 14, 1991, 183 days after the submission was received.
What is the product code of K903690?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.