Data / Medical devices / Low Energy Direct Current Thermal Ablation System
Low Energy Direct Current Thermal Ablation System (OAB): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Low Energy Direct Current Thermal Ablation System (product code OAB, Class 2, 21 CFR 878.4400). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on August 12, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OAB
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 3 |
| Italy | 1 |
Makers of Low Energy Direct Current Thermal Ablation System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 4 | March 24, 2026 | 0 | 3 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | March 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc | Glens Falls, NY, United States | Manufacturer | 3 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Galvanize Therapeutics | Redwood City, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | May 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canady Biotechnology LLC | Takoma Park, MD, United States | Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Surgnova Healthcare Technologies (zhejiang) Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Curaway Medical Technology Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Foreign private label distributor, Manufacturer | 1 | June 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Energenx Medical Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Igea SPA | Carpi (MO) Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meddux Development Corporation LLC | Boulder, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech | Olathe, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Salt Lake City, UT, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.