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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Angiodynamics, Inc. NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue.
Catalog Number: 20400111
UPN: H787204001110 Open, Classified |
OAB | K183385 |
| Apr 24, 2020 | Angiodynamics, Inc. AngioDynamics NanoKnife Disposable Single Electrode
Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103 Terminated |
OAB | K150089 |
| Jan 27, 2012 | Angiodynamics Worldwide Headquarters NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101
Terminated |
OAB | K080202 K102329 |
| Sep 23, 2011 | Angiodynamics, Inc. ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804
Intended to remove tissue and control bleeding by the use of high- frequency Terminated |
OAB | K080376 |
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