510(k) K163105 ยท NEY System, Ablation, Microwave And Accessories
Emprint Ablation System
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Dec 6, 2016 |
| Received | Nov 7, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Covidien LLC Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, inclu Open, Classified |
NEY | None listed |
| Nov 15, 2018 | Covidien LLC Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, incl Open, Classified |
NEY | None listed |
| Nov 15, 2018 | Covidien LLC Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including Open, Classified |
NEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.