510(k) K080202 ยท OAB Low Energy Direct Current Thermal Ablation System
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
| Applicant | Oncobionics, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, May 8, 2008 |
| Received | Jan 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.