510(k) K162449 ยท NEY System, Ablation, Microwave And Accessories
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
| Applicant | AngioDynamics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, May 5, 2017 |
| Received | Sep 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD Terminated |
NEY | None listed |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US Terminated |
NEY | None listed |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D Terminated |
NEY | None listed |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 Terminated |
NEY | None listed |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
Solero Generator PG
(1) Catalog Number:12740000
UPN: H78712740000
(2) Solero Generator US PG
Catalog Number: 12740000US
UPN: H787127400 Terminated |
NEY | None listed |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1) Solero Generator Refurbished PG
Catalog Number: 12740000D UPN: H78712740000D0
(2) Solero Generator Refurbished US PG
Catalog Number: Terminated |
NEY | None listed |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1) Solero Applicator 14cm PG
Catalog Number: 700106001
UPN:H7877001060010;
(2)Solero Applicator 14cm PG US
Catalog Number:700106001US
Terminated |
NEY | None listed |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1)Solero Applicator 19cm PG
Catalog Number: 700106002
UPN: H7877001060020
(2)Solero Applicator 19cm PG US
Catalog Number:700106002US
U Terminated |
NEY | None listed |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1)Solero Applicator 29cm PG
Catalog Number:700106003
UPN: H7877001060030
(2)Solero Applicator 29cm PG US
Catalog Number:700106003US
UPN Terminated |
NEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.