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)
II
2026-03-02
K252632
Nanjing Dewen Medical Technology Co., Ltd.
Microwave Ablation Device
II
2026-03-02
K251802
Merit Medical Systems, Inc.
STAR RF Ablation System
II
2026-02-13
K253915
Erbe Elektromedizin GmbH
MOVIVA® Hybrid Ablation Probe
II
2025-12-18
K252388
Francis Medical, Inc.
Vanquish Water Vapor Ablation Device
II
2025-11-26
K251226
Aqua Medical, Inc.
Aqua Medical RF Vapor Ablation System
II
2025-08-08
K250307
Medtronic Navigation
Visualase V2 MRI-guided Laser Ablation System (9736422)
II
2025-05-29
K250213
Stryker Instruments
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
II
2025-05-15
K250705
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
II
2025-04-02
K243042
Hygea Medical Technology Co., Ltd.
Co-Ablation System with Sterile Co-Ablation Probe
II
2025-01-29
K241271
Aqua Medical, Inc.
Aqua Medical RF Vapor Ablation System
II
2024-12-12
K241827
Canyon Medical, Inc.
Microwave Ablation Generator (KY-2000A, KY-2100A)
II
2024-09-26
K241825
Canyon Medical, Inc.
Microwave Ablation Antennas
II
2024-09-20
K234151
AtriCure, Inc.
Isolator Synergy EnCapture Ablation System (EMH)
II
2024-08-27
K240457
Pentax of America, Inc.
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
II
2024-07-24
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)
II
2024-07-19
K240503
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
II
2024-07-17
K240297
Us Medical Innovations, LLC
Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
II
2024-05-03
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)
II
2024-03-28
K233830
Medtronic Sofamor Danek USA, Inc.
OsteoCool 2.0 RF Ablation System
II
2024-02-28
K233140
Hygea Medical Technology Co., Ltd.
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
II
2024-01-31
K233848
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
II
2023-12-21
K231675
Neuroone Medical Technologies Corp.
OneRF Ablation System
II
2023-12-06
K231738
Neuwave Medical, Inc.
NEUWAVE Microwave Ablation System and Accessories
II
2023-11-16
K232240
Betters(Suzhou) Medical Co., Ltd.
Microwave Ablation System (BD-GT)
II
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)
II
2023-11-13
K223303
Axon Spine Medical System
Spinery RF Ablation System
II
2023-08-30
K223135
Compal Electronics, Inc.
AblatePal Radiofrequency Ablation System
II
2023-06-30
K222001
Zhejiang Curaway Medical Technology Co., Ltd.
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
II
2023-06-08
K223581
AngioDynamics, Inc.
Solero Microwave Tissue Ablation (MTA) System and Accessories
II
2023-03-27
K223488
Medtronic, Inc.
ClosureFast Endovenous Radiofrequency Ablation Catheter
II
2023-03-23
K221883
AngioDynamics, Inc.
Solero Microwave Tissue Ablation (MTA) System and Accessories
II
2023-03-07
K223272
Mima-Pro Scientific, Inc.
SurBlate Ablation System
II
2023-02-28
K221358
AtriCure, Inc.
Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
II
2022-12-30
K223094
ABBOTT MEDICAL
EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License
II
2022-12-27
K223508
Medtronic, Inc.
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
II
2022-12-22
K222304
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
II
2022-11-08
K222281
Relievant Medsystems, Inc.
Intracept Intraosseous Nerve Ablation System
II
2022-10-26
K220472
Neuwave Medical, Inc.
NEUWAVE Microwave Ablation System and Accessories
II
2022-08-11
K213836
Relievant Medsystems, Inc.
Intracept Intraosseous Nerve Ablation System
II
2022-03-11
K203150
Covidien, LLC
Cool-tip RF Ablation System E Series
II
2022-02-25
K211269
Medtronic Navigation, Inc.
Visualase MRI-Guided Laser Ablation System (SW 3.4)
II
2022-01-07
K213067
AngioDynamics, Inc.
Solero Microwave Tissue Ablation (MTA) System and Accessories
II
2021-12-03
K212814
Pentax of America, Inc.
C2 CryoBalloon Ablation System
II
2021-11-29
K210477
AtriCure, Inc.
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
II
2021-07-26
K211535
Gynesonics, Inc.
Sonata Transcervical Fibroid Ablation System 2.2
II
2021-06-17
K211311
AtriCure, Inc.
AtriCure Isolator® Synergy Surgical Ablation System
II
2021-05-28
K200697
AtriCure, Inc.
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
II
2020-12-23
K203303
Covidien, LLC
Emprint SX Ablation Platform with Thermosphere Technology
II
2020-12-17
K192406
Medwaves, Inc.
AveCure BT Microwave Ablation System
II
2020-11-25
K200081
Neuwave Medical, Inc.
NEUWAVE Microwave Ablation System and Accessories
II
2020-11-13
K202297
Mirada Medical, Ltd.
Aline Ablation Intelligence
II
2020-09-11
K200796
Covidien, LLC
Emprint Ablation System with Thermosphere Technology
II
2020-08-26
K200061
Galil Medical, Inc.
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
II
2020-07-09
K200514
Medtronic
Cardioblate Gemini-s Surgical Ablation Device
II
2020-06-03
K193516
Gynesonics, Inc.
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
II
2020-05-04
K193232
Covidien, LLC
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
II
2020-02-13
K192715
Cambridge Interventional, LLC
CRF Radiofrequency Ablation System
II
2020-01-07
K191073
Vein 360, LLC
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
II
2019-10-22
K191526
Medtronic, Inc.
Cardioblate CryoFlex Surgical Ablation System
II
2019-10-01
K183153
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Microwave Ablation System
II
2019-07-08
K190052
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Radio Frequency Ablation System
II
2019-06-25
K190623
Medtronic
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
II
2019-05-30
K190504
Relievant Medsystems
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
II
2019-05-03
K182250
AngioDynamics, Inc.
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
II
2019-02-28
K190151
AtriCure, Inc.
COBRA Fusion Ablation System
II
2019-02-25
K182497
Medtronic Sofamor Danek USA, Inc.
OsteoCool RF Ablation System
II
2019-01-15
K181864
Baylis Medical Company, Inc.
Polaris RF Ablation System
II
2019-01-02
K182610
Medtronic
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
II
2018-12-19
K173756
Neuwave Medical, Inc.
Certus 140 2.45GHz Ablation System
II
2018-10-24
K180369
Relievant Medsystems
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
II
2018-09-14
K173703
Gynesonics, Inc.
Sonata Sonography-Guided Transcervical Fibroid Ablation System
II
2018-08-15
K181044
AngioDynamics, Inc.
400um Perforator and Accessory Vein Ablation Kit
II
2018-07-05
K180192
Covidien, LLC
Emprint Ablation Visualization Application
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2018-03-21
K173740
Renovo, Inc.
Reprocessed DePuy Mitek Ablation Wand
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2018-03-19
K173741
Renovo, Inc.
Reprocessed ArthoCare Ablation Wand
II
2018-03-05
K180137
AtriCure, Inc.
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
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2018-02-15
K180138
AtriCure, Inc.
AtriCure cryoICE cryo-ablation probe (CRYO2)
II
2018-02-15
K163684
C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System
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2018-01-23
K171358
Coviden, LLC
Emprint SX Ablation Platform and Accessories
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2017-09-01
K170827
Relievant Medsystems
INTRACEPT Intraosseous Nerve Ablation System
II
2017-08-09
K162449
AngioDynamics, Inc.
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
II
2017-05-05
K163118
Neuwave Medical, Inc.
FLEX Microwave Ablation System and Accessories
II
2017-03-09
K161949
Baylis Medical Company, Inc.
OsteoCool V-3 RF Ablation System
II
2017-01-31
K161202
C2 Therapeutics, Inc.
C2 Cryoballoon Ablation System
II
2017-01-05
K160936
Neuwave Medical, Inc.
Certus 140 2.45GHz Ablation System
II
2016-05-04
K152329
C2 Therapeutics, Inc.
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
II
2016-04-13
K150019
Acoustic Medsystems, Inc.
TheraVision Ultrasound Ablation System and ACOUSTx Applicators
II
2016-01-13
K153541
C2 Therapeutics, Inc.
Coldplay CryoBalloon® Ablation System
II
2016-01-07
K152057
Baylis Medical Company, Inc.
OsteoCool V-3 RF Ablation System
II
2015-11-24
K143203
Medwaves Incorporated
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
II
2015-08-26
K151054
C2 Therapeutics, Inc.
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
II
2015-07-07
K142480
Baylis Medical Company, Inc.
OsteoCool V-2 RF Ablation System
II
2015-06-16