510(k) K181864 ยท GXD Generator, Lesion, Radiofrequency
Polaris RF Ablation System
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jan 2, 2019 |
| Received | Jul 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an a Terminated |
GEX | None listed |
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an Terminated |
GXI | None listed |
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an Terminated |
GXI | None listed |
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an Terminated |
GXI | None listed |
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an a Terminated |
GXI | None listed |
| Jun 8, 2020 | Medtronic Sofamor Danek USA Inc Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage:
(sterile, single-use) comprises an electrically insulated shaft, an Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.