Chrysalis Intelligence · Product Codes · NEY

NEY · System, Ablation, Microwave And Accessories

General, Plastic Surgery · 31 clearances · 16 unique sponsors

Device class
Class II
Regulation 878.4400
Total clearances
31
2020-02-13 → 2026-03-02
Last 12 months
2
Unique sponsors
16
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4400
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Creo Medical, Ltd. 4 0 2023-06-26
Emblation Limited 3 0 2025-08-08
Neuwave Medical, Inc. 3 0 2023-11-16
Covidien, LLC 3 0 2020-12-17
AngioDynamics, Inc. 3 0 2023-03-27
Betters(Suzhou) Medical Co., Ltd. 2 0 2023-11-13
Canyon Medical, Inc. 2 0 2024-09-26
Nanjing Eco Microwave System Co., Ltd. 2 0 2021-07-23
Varian Medical Systems, Inc. 2 0 2024-07-19
Galil Medical, Inc. 1 0 2020-07-09
Hygea Medical Technology Co., Ltd. 1 0 2024-01-31
Nanjing Dewen Medical Technology Co., Ltd. 1 1 2026-03-02
Medtronic, Inc. 1 0 2024-03-28
Mima-Pro Scientific, Inc. 1 0 2023-02-28
Medwaves, Inc. 1 0 2020-11-25
Nanjing Devin Medical Technology Co., Ltd. 1 1 2026-03-02
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
17000 CPT Medium Destruction of skin lesion by destructive method; microwave ablation fits this category
76940 CPT Medium Intraoperative ultrasonic guidance; may apply if imaging is integrated
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-02 K253771 Nanjing Devin Medical Technology Co., Ltd. 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)
2026-03-02 K252632 Nanjing Dewen Medical Technology Co., Ltd. Microwave Ablation Device
2025-08-08 K250718 Emblation Limited swiftPro System (SWF-SPS); Swift System (SWF-SYS)
2024-09-26 K241827 Canyon Medical, Inc. Microwave Ablation Generator (KY-2000A, KY-2100A)
2024-09-20 K241825 Canyon Medical, Inc. Microwave Ablation Antennas
2024-07-19 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); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
2024-05-29 K240784 Varian Medical Systems, Inc. Temperature Sensor Probe (ABL-18TP20)
2024-04-23 K240518 Emblation Limited swiftPro™ System
2024-03-28 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); 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)
2024-01-31 K233140 Hygea Medical Technology Co., Ltd. Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
2023-11-16 K231738 Neuwave Medical, Inc. NEUWAVE™ Microwave Ablation System and Accessories
2023-11-13 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)
2023-11-13 K232240 Betters(Suzhou) Medical Co., Ltd. Microwave Ablation System (BD-GT)
2023-06-26 K223138 Creo Medical, Ltd. AB1 Electrosurgical Instrument, Creo Electrosurgical System
2023-05-04 K222388 Emblation , Ltd. swiftPro System
2023-03-27 K223581 AngioDynamics, Inc. Solero Microwave Tissue Ablation (MTA) System and Accessories
2023-03-07 K221883 AngioDynamics, Inc. Solero Microwave Tissue Ablation (MTA) System and Accessories
2023-02-28 K223272 Mima-Pro Scientific, Inc. SurBlate Ablation System
2023-02-14 K221672 Creo Medical, Ltd. Creo Electrosurgical System with NP1 Instrument
2022-08-11 K220472 Neuwave Medical, Inc. NEUWAVE Microwave Ablation System and Accessories
2021-12-03 K213067 AngioDynamics, Inc. Solero Microwave Tissue Ablation (MTA) System and Accessories
2021-07-23 K201265 Nanjing Eco Microwave System Co., Ltd. Disposable Microwave Therapeutic Antennas
2021-07-09 K201262 Nanjing Eco Microwave System Co., Ltd. Microwave Therapeutic System
2021-01-05 K200298 Creo Medical, Ltd. ABI Instrument, Creo Electrosurgical System
2020-12-17 K203303 Covidien, LLC Emprint SX Ablation Platform with Thermosphere Technology