FDA.reportPublic FDA data

510(k) K222001

Device
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
510(k) number
K222001
Product code
OAB
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-08
Date received
2022-07-07
Regulation
878.4400
Classification name
Low Energy Direct Current Thermal Ablation System
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xiaoyu Guan
Address
Bldg. 1, #600, 21st St., Qiantang New Area Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K183385NanoKnife SystemAngiodynamics2019-06-18
K150089NanoKnife SystemAngioDynamics, Inc.2015-06-18
K102329NANOKNIFE SYSTEMAngioDynamics, Inc.2011-10-24
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K080376ONCOBIONIC SYSTEMOncobionic Incorporated2008-04-02
K060054ONCOBIONIC SYSTEMOncobionics, Inc.2006-11-21