Panels › General, Plastic Surgery › Product code OAB · Class 2
Low Energy Direct Current Thermal Ablation System
Regulation 878.4400
3510(k)s in 12 months (15 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OAB
| Company | 510(k)s | Recalls |
|---|---|---|
| AngioDynamics, Inc. | 5 | 3 |
| Galvanize Therapeutics, Inc. | 3 | 0 |
| Oncobionics, Inc. | 2 | 0 |
| Angiodynamics Worldwide Headquarters | 0 | 1 |
| Hangzhou Ruidi Biotechnology , Ltd. | 1 | 0 |
| Oncobionic Incorporated | 1 | 0 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 1 | 0 |
| Us Medical Innovations, LLC | 1 | 0 |
| Zhejiang Curaway Medical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2026 | K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pul Hangzhou Ruidi Biotechnology , Ltd., CN | OAB |
| May 7, 2026 | K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle Galvanize Therapeutics, Inc. | OAB |
| Mar 24, 2026 | K253198 | NanoKnife Generator (H78720300351US0) Angiodynamics | OAB |
| Dec 6, 2024 | K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Sin AngioDynamics, Inc. | OAB |
| Oct 4, 2024 | K240376 | Electroporation System (N3000) Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN | OAB |
| May 22, 2024 | K233884 | INUMI Flex Needle Galvanize Therapeutics, Inc. | OAB |
| May 3, 2024 | K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) Us Medical Innovations, LLC | OAB |
| Jun 8, 2023 | K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe Zhejiang Curaway Medical Technology Co., Ltd., CN | OAB |
| Jun 17, 2022 | K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode Galvanize Therapeutics, Inc. | OAB |
| Jun 18, 2019 | K183385 | NanoKnife System Angiodynamics | OAB |
| Jun 18, 2015 | K150089 | NanoKnife System AngioDynamics, Inc. | OAB |
| Oct 24, 2011 | K102329 | NANOKNIFE SYSTEM AngioDynamics, Inc. | OAB |
| May 8, 2008 | K080202 | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT Oncobionics, Inc. | OAB |
| Apr 2, 2008 | K080376 | ONCOBIONIC SYSTEM Oncobionic Incorporated | OAB |
| Nov 21, 2006 | K060054 | ONCOBIONIC SYSTEM Oncobionics, Inc. | OAB |
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