510(k) K012315 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
LEVEEN ELECTRODE
| Applicant | Radiotherapeutics Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 11, 2001 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2012 | Boston Scientific Corporation Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15).
Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation Terminated |
JOS | None listed |
| Oct 18, 2012 | Boston Scientific Corporation Leveen Coaccess Introducer Set.
Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, Terminated |
JOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.