NEY — System, Ablation, Microwave And Accessories Class II

FDA Device Classification

Classification Details

Product Code
NEY
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252632nanjing dewen medical technology coMicrowave Ablation DeviceMarch 2, 2026
K253771nanjing devin medical technology coDisposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-IIMarch 2, 2026
K250718emblation limitedswiftPro System (SWF-SPS); Swift System (SWF-SYS)August 8, 2025
K241827canyon medicalMicrowave Ablation Generator (KY-2000A, KY-2100A)September 26, 2024
K241825canyon medicalMicrowave Ablation AntennasSeptember 20, 2024
K240480varian medical systemsIntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave July 19, 2024
K240784varian medical systemsTemperature Sensor Probe (ABL-18TP20)May 29, 2024
K240518emblation limitedswiftPro™ SystemApril 23, 2024
K233838medtronicEmprint Ablation System with Thermosphere Technology (Overall System Name); EmprMarch 28, 2024
K233140hygea medical technology coMicrowave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (ExactJanuary 31, 2024
K231738neuwave medicalNEUWAVE™ Microwave Ablation System and AccessoriesNovember 16, 2023
K232241betters(suzhou) medical coDisposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-November 13, 2023
K232240betters(suzhou) medical coMicrowave Ablation System (BD-GT)November 13, 2023
K223138creo medicalAB1 Electrosurgical Instrument, Creo Electrosurgical SystemJune 26, 2023
K222388emblationswiftPro SystemMay 4, 2023
K223581angiodynamicsSolero Microwave Tissue Ablation (MTA) System and AccessoriesMarch 27, 2023
K221883angiodynamicsSolero Microwave Tissue Ablation (MTA) System and AccessoriesMarch 7, 2023
K223272mima-pro scientificSurBlate Ablation SystemFebruary 28, 2023
K221672creo medicalCreo Electrosurgical System with NP1 InstrumentFebruary 14, 2023
K220472neuwave medicalNEUWAVE Microwave Ablation System and AccessoriesAugust 11, 2022