510(k) K193232
- Device
- Emprint Ablation System With Thermosphere Technology, Emprint SX Ablation Platform With Thermosphere Technology
- Applicant
- Covidien LLC
- 510(k) number
- K193232
- Product code
- NEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-13
- Date received
- 2019-11-25
- 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
- Hilla Debby
- Address
- 6135 Gunbarrel Ave. Boulder CO US 80301 80301
FDA Registration Numbers#
- 1721686
- 3013440400
- 3001592626
- 1319211
- 3005382058
- 1721676
- 3017892510
- 3022977243
- 3006638824
- 3026612481
- 3039443404
- 3030234858
- 3015152398
- 3045005759
- 2246552
- 1928237
- 3007007790
- 3010933564
- 3015540957
- 3006451981
- 1526611
- 1724474
- 3008262715
- 3008769756
- 1717344
- 3013875526
- 3016688836
- 8010312
- 3004962788
- 3008082710
- 3020309549
- 1721983
- 3004636440
- 3014925413
- 3008132398
- 1000523114
- 3018094310
- 3008361498
- 3027728071
Source Documents#
Other 510(k) Records For Product Code NEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 |
| 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 |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | 2025-08-08 |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | 2024-09-26 |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | 2024-09-20 |
| 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 |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | 2024-05-29 |
| K240518 | swiftPro™ System | Emblation Limited | 2024-04-23 |
| 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 |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | 2024-01-31 |
| K231738 | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2023-11-16 |
| K232240 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 |
| 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 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023-06-26 |
| K222388 | swiftPro System | Emblation , Ltd. | 2023-05-04 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases