ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
FDA 510(k) K212166 · Inomed Medizintechnik GmbH
510(k) numberK212166
Submission
- Device name
- ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- Applicant
- Inomed Medizintechnik GmbH
Emmendingen, DE - Received
- July 12, 2021
- Decision date
- January 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | Alphatec Spine, Inc. | 04/19/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
More from Alphatec Spine, Inc.
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|---|---|---|
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…ETN · Traditional | 06/13/2025SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | 10/27/2023SE |
| K223254 | C2 XploreETN · Traditional | 01/27/2023SE |
| K212164 | Mapping Suction ProbeETN · Traditional | 11/11/2022SE |
| K152505 | C2 NerveMonitor SystemETN · Traditional | 02/01/2016SE |
| K111647 | C2 Nervemonitor System with AccessoriesGWF · Traditional | 10/06/2011SE |
| K091874 | Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656ETN · Traditional | 11/18/2009SE |
| K042208 | Isis Mer System/Elekta Mer SystemGZL · Traditional | 03/18/2005SE |
| K910972 | Walter GraphtekGWQ · Traditional | 10/02/1991SE |
Questions and answers
When was ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress cleared by the FDA?
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166) received a 510(k) decision of Substantially Equivalent on January 7, 2022, 179 days after the submission was received.
What is the product code of K212166?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.