510(k) K053128 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Nov 30, 2005 |
| Received | Nov 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2012 | Boston Scientific Corporation Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA.
The Soloist Needle Electrode is intend Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.