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 |
| K242687 | Angiodynamics, Inc. | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | 12/06/2024 |
| 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 |
| K233884 | Galvanize Therapeutics, Inc. | INUMIÖ Flex Needle | 05/22/2024 |
| 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 |
| K240376 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Electroporation System (N3000) | 10/04/2024 |
| K240297 | US Medical Innovations, LLC | Canady Helios Cold PlasmaÖ XL-1000CPÖ Ablation System (XL-1000CPSYS) | 05/03/2024 |
| K222001 | Zhejiang CuraWay Medical Technology Co., Ltd. | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | 06/08/2023 |
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