510(k) K000032 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
LEVEEN NEEDLE ELECTRODE
| Applicant | Radiotherapeutics Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 30, 2000 |
| Received | Jan 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2012 | Boston Scientific Corporation LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25).
Disposable, monopolar, electrosurgical devices, intended for use in conjunct Terminated |
GEI | None listed |
| Sep 9, 2009 | Boston Scientific Corp Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation. Terminated |
GEI | None listed |
| Sep 9, 2009 | Boston Scientific Corp Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.