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Low Energy Direct Current Thermal Ablation System
FDA product code OAB · Class 2 · General, Plastic Surgery
69
Registered devices
233
Adverse events
4
Recalls
15
510(k) clearances
Devices with this code
NanoKnife — Angiodynamics, Inc.NanoKnife — ANGIODYNAMICS, INC.INUMI Flex Needle — Galvanize Therapeutics, Inc.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.NanoKnife — Angiodynamics, Inc.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.NanoKnife — ANGIODYNAMICS, INC.NanoKnife — ANGIODYNAMICS, INC.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.NanoKnife — ANGIODYNAMICS, INC.NanoKnife — ANGIODYNAMICS, INC.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.Aliya EX Generator — Galvanize Therapeutics, Inc.Curaway — Zhejiang CuraWay Medical Technology Co., Ltd.NanoKnife — ANGIODYNAMICS, INC.Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.Aliya Needle — Galvanize Therapeutics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-02 | Angiodynamics, Inc. | Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoK |
| 2020-04-24 | Angiodynamics, Inc. | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. |
| 2012-01-20 | Angiodynamics Worldwide Headquarters | Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance. |
| 2011-04-04 | Angiodynamics, Inc. | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board wh |
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