Phantom XL Insulated Dilators
FDA 510(k) K231691 · TeDan Surgical Innovations, Inc.
510(k) numberK231691
Submission
- Device name
- Phantom XL Insulated Dilators
- Applicant
- TeDan Surgical Innovations, Inc.
Sugar Land, TX, US - Received
- June 9, 2023
- Decision date
- June 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K161566 | DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional | Daehan Medical Systems Co., Ltd. | 12/21/2016SE |
| K142470 | E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special | Neuroinvent, Inc. | 11/05/2014SE |
| K140200 | E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional | Neuroinvent, Inc. | 07/18/2014SE |
| K130220 | MR Conditional Presson ElectrodeGXZ · Traditional | Rhythmlink International, LLC | 07/22/2013SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | Technomed Europe | 07/19/2013SE |
More from Technomed Europe
| 510(k) | Device | Decision |
|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…PDQ · Traditional | 04/26/2026SE |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | 03/20/2017SE |
| K140088 | Phantom XL Insulated DilatorsPDQ · Traditional | 09/25/2014SE |
Questions and answers
When was Phantom XL Insulated Dilators cleared by the FDA?
Phantom XL Insulated Dilators (K231691) received a 510(k) decision of Substantially Equivalent on June 29, 2023, 20 days after the submission was received.
What is the product code of K231691?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.