FDA.report

Radio-frequency ablation system

Definition
An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).
GUDID devices
697
Last updated
2023-05-31 09:09:25

Related Product Codes

CodeDeviceSpecialtyClassDevices
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2397
GXIProbe, Radiofrequency LesionNeurology2192
GXDGenerator, Lesion, RadiofrequencyNeurology274
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology29
ITXTransducer, Ultrasonic, DiagnosticRadiology26
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery25
OOYBronchial Thermoplasty SystemUnknown35
MNBDevice, Thermal Ablation, EndometrialUnknown34
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology21
OEWTracking, Soft Tissue, IntraoperativeNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
15420045515246Acessa ProVu SystemHologic, Inc.73002023-05-16
15420045515253Acessa ProVu SystemHologic, Inc.30002023-05-16
15420045515307Acessa ProVu SystemHologic, Inc.71002023-05-16
15420045515314Acessa ProVu SystemHologic, Inc.MS-06-01712023-05-16
15420045515154NovaSureHologic, Inc.V52023-04-22
10884521181298BarrxCovidien LPFLEXCC-020A2022-04-07
10884521181304BarrxCovidien LPFLEXFS-010A2022-04-07
00811746032718CableAPECAMBRIDGE INTERVENTIONAL LLCCRF-APE2022-03-31
00811746032770ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N2010E2022-03-31
10811746032722ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N0610E2022-03-31
10811746032739ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1010E2022-03-31
10811746032746ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1015E2022-03-31
10811746032753ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1610E2022-03-31
10811746032760ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1615E2022-03-31
10811746032784ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N2015E2022-03-31
10811746032791ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N2510E2022-03-31
10811746032807ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N2515E2022-03-31
10811746032814ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1110E2022-03-31
10811746032821ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-N1115E2022-03-31
10811746032838ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1505S2022-03-31
10811746032845ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1505P2022-03-31
08714729968313NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-4-120V2017-09-11
08714729968320NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-4-120VD2017-09-11
08714729968337NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-4-120VH2017-09-11
08714729968344NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-4-120VR2017-09-11
08714729968351NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-4-120VZ2017-09-11
06972304750209DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.R150E2022-03-07
16972304750022DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-15102022-03-07
16972304750039DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-15202022-03-07
16972304750046DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-15302022-03-07
16972304750053DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-20102022-03-07
16972304750060DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-20202022-03-07
16972304750077DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-20302022-03-07
16972304750084DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-20402022-03-07
16972304750091DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-25102022-03-07
16972304750107DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-25202022-03-07
16972304750114DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-25302022-03-07
16972304750121DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS1-25402022-03-07
16972304750138DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-07052022-03-07
16972304750145DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-07072022-03-07
16972304750152DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-07102022-03-07
16972304750169DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-07152022-03-07
16972304750176DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-15102022-03-07
16972304750183DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-15152022-03-07
16972304750190DophiSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.SS-RFAS2-15202022-03-07
10884521660694BarrxCovidien LP1190A-230A-012016-09-24
20884521189390BarrxCovidien LP90-95002016-09-24
10860036000545Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-7-602021-10-26
10860036000552Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-7-1002021-10-26
10860036000569Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-3-602021-10-26
00763000157845OsteoCool™ RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC042021-10-08
10884521177796BarrxCovidien LP1190A-115A2016-09-24
15420045514294NovaSureHologic, Inc.V52021-07-02
15420045514300NovaSureHologic, Inc.V52021-07-02
25420045514307NovaSureHologic, Inc.V52021-07-02
08600360005008Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-7-1002021-06-17
08600360005022Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-3-602021-06-17
08600360005107Endovenous Radiofrequency Ablation (RFA) CatheterVein360 LLCVEN-7-602021-06-17
00191506013684SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFK-C101018S-ZK22021-04-28
00191506013691SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFK-C101020S-ZK22021-04-28
00191506013707SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFK-C151018S-ZK22021-04-28
00191506013714SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFK-C151020S-ZK22021-04-28
08714729796695Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONATS 2002014-09-24
08714729802778Alair™BOSTON SCIENTIFIC CORPORATIONM005ATS201102014-09-24
08714729802792ALAIR™BOSTON SCIENTIFIC CORPORATIONM005ATS250102014-09-24
08714729802822Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONATS 2002014-09-24
08714729961154Alair Bronchial Thermoplasty RF ControllerBOSTON SCIENTIFIC CORPORATIONATS 2002017-08-07
00854763006256Acessa ProVu Dual Foot Pedal ACESSA HEALTH INC.MS-06-01712020-12-07
00811746030677CableAMGCAMBRIDGE INTERVENTIONAL LLCCRF-AMG2020-10-16
00811746031469ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1007S2020-10-16
00811746031476ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1010S2020-10-16
00811746031483ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1015S2020-10-16
00811746031490ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1020S2020-10-16
00811746031506ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1025S2020-10-16
10811746031510ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1030S2020-10-16
10811746031527ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1035S2020-10-16
10811746031534ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1040S2020-10-16
10811746031541ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1045S2020-10-16
10811746031558ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1050S2020-10-16
10811746031565ElectrodeCRFCAMBRIDGE INTERVENTIONAL LLCCRF-U1507S2020-10-16