FDA.reportPublic FDA data

510(k) K233838

Device
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 Percu
Applicant
Medtronic, Inc.
510(k) number
K233838
Product code
NEY
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-28
Date received
2023-12-04
Regulation
878.4400
Classification name
System, Ablation, Microwave And Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Steve Pavlik
Address
200 Medtronic Dr. Lafayette CO US 80026 80026

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253771Disposable 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
K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.2026-03-02
K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited2025-08-08
K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.2024-09-26
K241825Microwave Ablation AntennasCanyon Medical, Inc.2024-09-20
K240480IntelliBlate 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
K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.2024-05-29
K240518swiftPro™ SystemEmblation Limited2024-04-23
K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.2024-01-31
K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2023-11-16
K232241Disposable 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
K232240Microwave Ablation System (BD-GT)Betters(Suzhou) Medical Co., Ltd.2023-11-13
K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.2023-06-26
K222388swiftPro SystemEmblation , Ltd.2023-05-04
K223581Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc.2023-03-27