FDA Product Code
FDA Product Code NEY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 68 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. | 2026-03-02 | Traditional | PDF ↗ |
| K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 | Traditional | PDF ↗ |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | 2025-08-08 | Traditional | PDF ↗ |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | 2024-09-26 | Traditional | PDF ↗ |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K240480 | 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); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. | 2024-07-19 | Traditional | PDF ↗ |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | 2024-05-29 | Traditional | PDF ↗ |
| K240518 | swiftPro System | Emblation Limited | 2024-04-23 | Traditional | PDF ↗ |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. | 2024-03-28 | Special | PDF ↗ |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | 2024-01-31 | Traditional | PDF ↗ |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2023-11-16 | Traditional | PDF ↗ |
| K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 | Traditional | PDF ↗ |
| K232240 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 | Traditional | PDF ↗ |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023-06-26 | Traditional | PDF ↗ |
| K222388 | swiftPro System | Emblation , Ltd. | 2023-05-04 | Traditional | PDF ↗ |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023-03-27 | Special | PDF ↗ |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023-03-07 | Special | PDF ↗ |
| K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | 2023-02-28 | Traditional | PDF ↗ |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | 2023-02-14 | Traditional | PDF ↗ |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2021-12-03 | Special | PDF ↗ |
| K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | 2021-07-09 | Traditional | PDF ↗ |
| K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021-01-05 | Traditional | PDF ↗ |
| K203303 | Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC | 2020-12-17 | Special | PDF ↗ |
| K192406 | AveCure BT Microwave Ablation System | Medwaves, Inc. | 2020-11-25 | Traditional | PDF ↗ |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2020-11-13 | Traditional | PDF ↗ |
| K200003 | NP1 Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2020-10-28 | Traditional | PDF ↗ |
| K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | 2020-08-26 | Traditional | PDF ↗ |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | Galil Medical, Inc. | 2020-07-09 | Traditional | PDF ↗ |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC | 2020-02-13 | Special | PDF ↗ |
| K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-07-08 | Traditional | PDF ↗ |
| K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | AngioDynamics, Inc. | 2019-02-28 | Traditional | PDF ↗ |
| K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K181941 | Swift System | Emblation , Ltd. | 2018-10-18 | Traditional | PDF ↗ |
| K180396 | miraDry System | Miramar Labs, Inc. | 2018-03-15 | Special | PDF ↗ |
| K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017-09-01 | Traditional | PDF ↗ |
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | AngioDynamics, Inc. | 2017-05-05 | Traditional | PDF ↗ |
| K163118 | FLEX Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2017-03-09 | Traditional | PDF ↗ |
| K163105 | Emprint Ablation System | Covidien, LLC | 2016-12-06 | Special | PDF ↗ |
| K160141 | miraDry System | Miramar Labs, Inc. | 2016-10-31 | Traditional | PDF ↗ |
| K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2016-05-04 | Special | PDF ↗ |
| K143203 | 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 | Medwaves Incorporated | 2015-08-26 | Traditional | PDF ↗ |
| K141785 | MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES | Bsd Medical Corp. | 2015-03-31 | Traditional | PDF ↗ |
| K133821 | EMPRINT ABLATION SYSTEM | Covidien, LLC | 2014-04-28 | Traditional | PDF ↗ |
| K130399 | CERTUS 140 CERTUSURGGT SURGICAL TOOL | Neuwave Medical, Inc. | 2013-07-18 | Traditional | PDF ↗ |
| K122217 | CERTUS 140 2.45GHZ ABLATION SYSTEM | Neuwave Medical, Inc. | 2012-12-19 | Traditional | PDF ↗ |
| K122762 | ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR | Microsulis Medical Limited | 2012-11-30 | Traditional | PDF ↗ |
| K113237 | CERTUS 140 2.45GHZ ABLATION SYSTEM | Neuwave Medical, Inc. | 2012-01-04 | Traditional | PDF ↗ |
| K100744 | CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 | Neuwave Medical, Inc. | 2010-10-22 | Traditional | PDF ↗ |
| K100786 | MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX | Bsd Medical Corp. | 2010-08-13 | Traditional | PDF ↗ |
| K094021 | ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I | Microsulis Medical Limited | 2010-08-06 | Traditional | PDF ↗ |
| K083157 | HS AMICA | H.S Hospital Service S.P.A | 2009-09-29 | Traditional | PDF ↗ |
| K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 | Miramar Labs, Inc. | 2009-03-20 | Traditional | PDF ↗ |
| K082565 | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 | Microsurgeon, Inc. | 2009-02-12 | Traditional | PDF ↗ |
| K083537 | MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM | Medwaves Incorporated | 2009-01-15 | Special | PDF ↗ |
| K072687 | VALLEYLAB MICROWAVE ABLATION GENERATOR | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008-11-25 | Traditional | PDF ↗ |
| K081042 | MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES | Bsd Medical Systems Corp. | 2008-09-03 | Traditional | PDF ↗ |
| K072870 | MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) | Foundry Newco X, Inc. | 2008-01-14 | Traditional | PDF ↗ |
| K070356 | MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM | Medwaves Incorporated | 2007-12-18 | Traditional | PDF ↗ |
| K070023 | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 | Microsurgeon, Inc. | 2007-08-15 | Traditional | PDF ↗ |
| K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | Guidant Corp. | 2006-07-27 | Special | PDF ↗ |
| K053535 | VIVAWAVE MICROWAVE ABLATION SYSTEM | Valleylab | 2006-04-27 | Traditional | PDF ↗ |
| K052919 | MICROSULIS TISSUE ABLATION SYSTEM | Microsulis Americas, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K041340 | GUIDANT MICROWAVE ABLATION SYSTEM | Guidant Corporation, Cardiac Surgery | 2004-07-28 | Traditional | PDF ↗ |
| K011676 | VIVAWAVE MICROWAVE SYSTEM | Vivant Medical, Inc. | 2002-06-18 | Traditional | PDF ↗ |
| K013946 | FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM | Afx, Inc. | 2002-02-27 | Traditional | PDF ↗ |
| K003978 | AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 | Afx, Inc. | 2001-05-22 | Traditional | PDF ↗ |
Product code NEY · Class II · General, Plastic Surgery. Data: openFDA.