510(k) K150089 ยท OAB Low Energy Direct Current Thermal Ablation System
NanoKnife System
| Applicant | AngioDynamics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jun 18, 2015 |
| Received | Jan 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150089
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.