510(k) K080376 ยท OAB Low Energy Direct Current Thermal Ablation System
ONCOBIONIC SYSTEM
| Applicant | Oncobionic Incorporated, Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Apr 2, 2008 |
| Received | Feb 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.