Dexus Prosthetic System (MSL2, MSR2)
FDA 510(k) K262654 · Zhejiang Qiangnao Technology Co.,Ltd
510(k) numberK262654
Submission
- Device name
- Dexus Prosthetic System (MSL2, MSR2)
- Applicant
- Zhejiang Qiangnao Technology Co.,Ltd
Hangzhou, CN - Received
- July 30, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional | Ambu A/S | 07/14/2026SE |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated | Cadwell Industries, Inc. | 06/26/2026SE |
| K261522 | BioWave BioWrapsGXY · Special | Biowave Corporation | 06/03/2026SE |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 05/08/2026SE |
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | Technomed Europe | 05/07/2026SE |
| K252439 | Tutamen Self Adhesive ElectrodesGXY · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 05/01/2026SE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | Ceribell, Inc. | 04/03/2026SE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special | Bionit Labs Srl | 03/12/2026SE |
| K254033 | Ceribell Instant EEG HeadsetGXY · Abbreviated | Ceribell, Inc. | 02/09/2026SE |
More from Ceribell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1)GXY · Traditional | 09/09/2022SE |
Questions and answers
When was Dexus Prosthetic System (MSL2, MSR2) cleared by the FDA?
Dexus Prosthetic System (MSL2, MSR2) (K262654) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 28 days after the submission was received.
What is the product code of K262654?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.