Aliya Needle
Aliya Needle is the needle component of a soft tissue ablation system that delivers pulsed electric fields. It is a 19-gauge, 20 cm needle with a 1 cm exposed distal tip and a nested…
Aliya Needle is the needle component of a soft tissue ablation system that delivers pulsed electric fields. It is a 19-gauge, 20 cm needle with a 1 cm exposed distal tip and a nested stylet.
The needle connects with a separate Aliya Electrode, which includes a probe, cable and generator plug. Together they form the monopolar ablation device that delivers the generator’s short electrical pulses at the needle’s exposed tip.
Listed Item
Aliya Needle, 5 pack
Connection to the System
The electrode probe is 21 cm long and connects to the generator through a three-meter cable. The system uses a cardiac monitor’s ECG trigger to synchronize energy delivery with the patient’s cardiac cycle. The needle and electrode are supplied as sterile, single-use components.
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 2) |
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, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GTI-00023 | In distribution | |
| GTI-00023 | 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 Generator | Galvanize Therapeutics | 1 |
| Aliya Electrode | 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.