Aliya Electrode
The Aliya Electrode connects the Aliya Generator to the Aliya Needle as part of a monopolar soft tissue ablation instrument. It carries pulsed electric field energy for delivery through the…
The Aliya Electrode connects the Aliya Generator to the Aliya Needle as part of a monopolar soft tissue ablation instrument. It carries pulsed electric field energy for delivery through the needle to the targeted tissue. The electrode and needle are sterile, single-use components.
The electrode includes a 21 cm probe that connects with the needle, a 3-metre cable and a plug for the generator. When assembled, the ablation device delivers energy through the distal 1 cm of the needle.
Listed Item
Aliya Electrode, 5 pack
Energy Control
The Aliya Generator interfaces with a cardiac monitor that detects the electrocardiogram R-wave. The generator uses these trigger signals to synchronize energy delivery with the patient’s cardiac cycle and permits delivery only within its acceptable heart-rate limits.
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Energenx Medical Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Galvanize Therapeutics, United States |
|---|---|
| FDA product code | OAB |
| Device type | Low Energy Direct Current Thermal Ablation System |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212871 |
| Record published | 2024-02-21 |
| Record revised | 2026-05-15 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GTI-00024 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 25 |
| NanoKnife | AngioDynamics, Inc. | 25 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 8 |
| Aliya Needle | Galvanize Therapeutics | 2 |
| Aliya Generator | Galvanize Therapeutics | 1 |
| US Medical Innovations | US Medical Innovations, LLC | 1 |
| Aliya PEF Ablation Pack | Galvanize Therapeutics | 1 |
| Aliya Generator-Recertified | Galvanize Therapeutics | 1 |
| Inumi Flex Needle | Galvanize Therapeutics | 1 |
| Inumi Flex Needle Pack | Galvanize Therapeutics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253826 | 2026-05-07 |
| K233884 | 2024-05-22 |
| K212871 | 2022-06-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.