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Curaway

Zhejiang CuraWay Medical Technology Co., Ltd. · Model CNP-III · UDI-DI 06936666557944

OAB Prescription

510(k) clearances

233

Adverse events (9 deaths)

Recalls

Facilities

Description

Irreversible Electroporation Ablation Generator

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 NanoKnife generator resul
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 which may cause the ge

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.