510(k) K161305 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Habib EUS RFA
| Applicant | Emcision , Ltd., London, GB |
| Decision | Substantially Equivalent, Jul 7, 2016 |
| Received | May 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161305
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2019 | Boston Scientific Corporation Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible Terminated |
JOS | None listed |
| Nov 18, 2019 | Boston Scientific Corporation Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible Terminated |
JOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.