FDA 510(k) Applications for Medical Device Product Code "NEY"
(System, Ablation, Microwave And Accessories)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003978 | AFX, INC. | AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 | 05/22/2001 |
| K013946 | AFX, INC. | FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM | 02/27/2002 |
| K162449 | ANGIODYNAMICS, INC | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | 05/05/2017 |
| K213067 | AngioDynamics, Inc. | Solero Microwave Tissue Ablation (MTA) System and Accessories | 12/03/2021 |
| K221883 | AngioDynamics, Inc. | Solero Microwave Tissue Ablation (MTA) System and Accessories | 03/07/2023 |
| K223581 | AngioDynamics, Inc. | Solero Microwave Tissue Ablation (MTA) System and Accessories | 03/27/2023 |
| K182250 | AngioDynamics, Inc. | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | 02/28/2019 |
| K232240 | Betters (Suzhou)Medical Co., Ltd. | Microwave Ablation System (BD-GT) | 11/13/2023 |
| K232241 | Betters(Suzhou) Medical Co., Ltd | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | 11/13/2023 |
| K141785 | BSD MEDICAL CORP. | MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES | 03/31/2015 |
| K100786 | BSD MEDICAL CORP. | MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX | 08/13/2010 |
| K081042 | BSD MEDICAL SYSTEMS CORP. | MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES | 09/03/2008 |
| K241825 | Canyon Medical Inc. | Microwave Ablation Antennas | 09/20/2024 |
| K241827 | Canyon Medical Inc. | Microwave Ablation Generator (KY-2000A, KY-2100A) | 09/26/2024 |
| K171358 | Coviden llc | Emprint SX Ablation Platform and Accessories | 09/01/2017 |
| K133821 | Covidien LLC | EMPRINT ABLATION SYSTEM | 04/28/2014 |
| K163105 | COVIDIEN LLC | Emprint Ablation System | 12/06/2016 |
| K200796 | Covidien LLC | Emprint Ablation System with Thermosphere Technology | 08/26/2020 |
| K193232 | Covidien LLC | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology | 02/13/2020 |
| K072687 | COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON | VALLEYLAB MICROWAVE ABLATION GENERATOR | 11/25/2008 |
| K203303 | Covidien, LLC | Emprint SX Ablation Platform with Thermosphere Technology | 12/17/2020 |
| K223138 | Creo Medical Ltd. | AB1 Electrosurgical Instrument, Creo Electrosurgical System | 06/26/2023 |
| K200298 | Creo Medical Ltd. | ABI Instrument, Creo Electrosurgical System | 01/05/2021 |
| K221672 | Creo Medical Ltd. | Creo Electrosurgical System with NP1 Instrument | 02/14/2023 |
| K200003 | Creo Medical Ltd. | NP1 Instrument, Creo Electrosurgical System | 10/28/2020 |
| K240518 | Emblation Limited | swiftProÖ System | 04/23/2024 |
| K181941 | Emblation Ltd | Swift System | 10/18/2018 |
| K222388 | Emblation Ltd. | swiftPro System | 05/04/2023 |
| K072870 | FOUNDRY NEWCO X, INC. | MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) | 01/14/2008 |
| K200061 | Galil Medical Inc. | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | 07/09/2020 |
| K061865 | GUIDANT CORP. | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | 07/27/2006 |
| K041340 | GUIDANT CORPORATION, CARDIAC SURGERY | GUIDANT MICROWAVE ABLATION SYSTEM | 07/28/2004 |
| K083157 | H.S HOSPITAL SERVICE S.P.A. | HS AMICA | 09/29/2009 |
| K233140 | Hygea Medical Technology Co., Ltd. | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | 01/31/2024 |
| K233838 | Medtronic, Inc | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); CovidienÖ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneo | 03/28/2024 |
| K143203 | MEDWAVES INCORPORATED | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe | 08/26/2015 |
| K070356 | MEDWAVES INCORPORATED | MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM | 12/18/2007 |
| K083537 | MEDWAVES INCORPORATED | MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM | 01/15/2009 |
| K192406 | MedWaves, Inc. | AveCure BT Microwave Ablation System | 11/25/2020 |
| K052919 | MICROSULIS AMERICAS, INC. | MICROSULIS TISSUE ABLATION SYSTEM | 01/13/2006 |
| K122762 | MICROSULIS MEDICAL LIMITED | ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR | 11/30/2012 |
| K094021 | MICROSULIS MEDICAL LIMITED | ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I | 08/06/2010 |
| K070023 | MICROSURGEON, INC. | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 | 08/15/2007 |
| K082565 | MICROSURGEON, INC. | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 | 02/12/2009 |
| K223272 | Mima-Pro Scientific Inc. | SurBlate Ablation System | 02/28/2023 |
| K082819 | MIRAMAR LABS, INC. | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 | 03/20/2009 |
| K160141 | Miramar Labs, Inc. | miraDry System | 10/31/2016 |
| K180396 | Miramar Labs, Inc. | miraDry System | 03/15/2018 |
| K201262 | Nanjing ECO Microwave System Co., Ltd | Microwave Therapeutic System | 07/09/2021 |
| K201265 | Nanjing ECO Microwave System Co., Ltd. | Disposable Microwave Therapeutic Antennas | 07/23/2021 |
| K220472 | NeuWave Medical Inc. | NEUWAVE Microwave Ablation System and Accessories | 08/11/2022 |
| K122217 | NEUWAVE MEDICAL, INC | CERTUS 140 2.45GHZ ABLATION SYSTEM | 12/19/2012 |
| K160936 | NEUWAVE MEDICAL, INC | Certus 140 2.45GHz Ablation System | 05/04/2016 |
| K100744 | NEUWAVE MEDICAL, INC | CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 | 10/22/2010 |
| K113237 | NEUWAVE MEDICAL, INC. | CERTUS 140 2.45GHZ ABLATION SYSTEM | 01/04/2012 |
| K173756 | NeuWave Medical, Inc. | Certus 140 2.45GHz Ablation System | 10/24/2018 |
| K130399 | NEUWAVE MEDICAL, INC. | CERTUS 140 CERTUSURGGT SURGICAL TOOL | 07/18/2013 |
| K163118 | NEUWAVE MEDICAL, INC. | FLEX Microwave Ablation System and Accessories | 03/09/2017 |
| K200081 | NeuWave Medical, Inc. | NEUWAVE Microwave Ablation System and Accessories | 11/13/2020 |
| K231738 | NeuWave Medical, Inc. | NEUWAVEÖ Microwave Ablation System and Accessories | 11/16/2023 |
| K183153 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Microwave Ablation System | 07/08/2019 |
| K053535 | VALLEYLAB | VIVAWAVE MICROWAVE ABLATION SYSTEM | 04/27/2006 |
| K240480 | Varian Medical Systems, Inc. | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBla | 07/19/2024 |
| K240784 | Varian Medical Systems, Inc. | Temperature Sensor Probe (ABL-18TP20) | 05/29/2024 |
| K011676 | VIVANT MEDICAL, INC. | VIVAWAVE MICROWAVE SYSTEM | 06/18/2002 |
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