Panels › General, Plastic Surgery › Product code NEY · Class 2
System, Ablation, Microwave And Accessories
Regulation 878.4400
2510(k)s in 12 months (68 all time)
0recalls in 12 months (27 all time)
25recalls that name a 510(k)
Top companies in NEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien, LLC | 5 | 11 |
| AngioDynamics, Inc. | 5 | 10 |
| Neuwave Medical, Inc. | 10 | 0 |
| Angiodynamics Inc. (Navilyst Medical Inc.) | 0 | 5 |
| Creo Medical, Ltd. | 4 | 0 |
| Emblation , Ltd. | 4 | 0 |
| Medwaves Incorporated | 4 | 0 |
| Miramar Labs, Inc. | 3 | 0 |
| Afx, Inc. | 2 | 0 |
| Betters(Suzhou) Medical Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2023 | Covidien, LLC COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1 Open, Classified |
NEY | None listed |
| Sep 29, 2021 | Covidien Llc Covidien Emprint Ablation Catheter with
Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 Terminated |
NEY | None listed |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 Terminated |
NEY | K162449 |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D Terminated |
NEY | K162449 |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US Terminated |
NEY | K162449 |
| Jul 20, 2021 | Angiodynamics, Inc. Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD Terminated |
NEY | K162449 |
| 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 | K162449 |
| 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 | K162449 |
| 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 | K162449 |
| 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 | K162449 |
| 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 | K162449 |
| 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 | K163105 |
| 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 | K163105 |
| 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 | K163105 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2 Open, Classified |
NEY | K133821 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 Open, Classified |
NEY | K133821 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2 Open, Classified |
NEY | K133821 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1 Open, Classified |
NEY | K133821 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2 Open, Classified |
NEY | K133821 |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 Open, Classified |
NEY | K133821 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis A Terminated |
NEY | K094021 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis Accu2i pM Terminated |
NEY | K094021 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis Accu Terminated |
NEY | K094021 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis Accu2i Terminated |
NEY | K094021 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis Accu2i pMTA M Terminated |
NEY | K094021 |
| Jun 5, 2017 | Angiodynamics, Inc. Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.
Product Usage:
The Acculis Accu2i pMT Terminated |
NEY | K094021 |
| Mar 17, 2016 | Covidien Medical Products (Shanghai) Manufacturing L.L.C. Short Percutaneous Antenna with Thermosphere" Technology
Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. Terminated |
NEY | K133821 |
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