FDA 510(k) Applications for Medical Device Product Code "OAB"
(Low Energy Direct Current Thermal Ablation System)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K183385 |
Angiodynamics |
NanoKnife System |
06/18/2019 |
K102329 |
ANGIODYNAMICS, INC. |
NANOKNIFE SYSTEM |
10/24/2011 |
K150089 |
ANGIODYNAMICS, INC. |
NanoKnife System |
06/18/2015 |
K212871 |
Galvanize Therapeutics, Inc. |
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode |
06/17/2022 |
K080376 |
ONCOBIONIC INCORPORATED |
ONCOBIONIC SYSTEM |
04/02/2008 |
K060054 |
ONCOBIONICS, INC. |
ONCOBIONIC SYSTEM |
11/21/2006 |
K080202 |
ONCOBIONICS, INC. |
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT |
05/08/2008 |
K222001 |
Zhejiang CuraWay Medical Technology Co., Ltd. |
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe |
06/08/2023 |
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