Probe, Radiofrequency Lesion

Product Code: GXI

Neurology Microwave Medical Products

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 882.4725


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as GXI

3659Probe, Radiofrequency LesionRadiofrequency Lesion Probe.

Total Product Life Cycle (TPLC) Devices

3659Probe, Radiofrequency LesionRadiofrequency Lesion Probe.

Pre-market Notifications for GXI

K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.
K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc.
K191293LCCS VC-S RF CannulaLCCS Products Limited
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorRelievant Medsystems
K190259Vesta RF CannulaBiomerics
K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.
K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems
K170708OWL RF INSULATED CANNULAEDiros Technology Inc.
K163461Coolief* Cooled RF ProbeHalyard Health, Inc.
K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc.
K153272INTRACEPT Flexible Bi-Polar RF Probe And Easy Access Instrument SetRELIEVANT MEDSYSTEMS
K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLCCS PRODUCTS LIMITED

Global Unique Device Identification Database

00813250018073PROBE, RADIOFREQUENCY LESION
00813250018059PROBE, RADIOFREQUENCY LESION
00813250018035PROBE, RADIOFREQUENCY LESION
00813250018011PROBE, RADIOFREQUENCY LESION
00813250017977PROBE, RADIOFREQUENCY LESION
00813250017779PROBE, RADIOFREQUENCY LESION
00813250017755PROBE, RADIOFREQUENCY LESION
00813250017731PROBE, RADIOFREQUENCY LESION
00813250017717PROBE, RADIOFREQUENCY LESION
00813250017632PROBE, RADIOFREQUENCY LESION
00813250017625PROBE, RADIOFREQUENCY LESION
00813250017601PROBE, RADIOFREQUENCY LESION
00813250017557PROBE, RADIOFREQUENCY LESION
00813250017540PROBE, RADIOFREQUENCY LESION
00813250017526PROBE, RADIOFREQUENCY LESION

Maude Adverse Events

PROBE, RADIOFREQUENCY LESIONBOSTON SCIENTIFIC NEUROMODULATION2020-03-09
PROBE, RADIOFREQUENCY LESIONBOSTON SCIENTIFIC NEUROMODULATION2020-03-09
PROBE, RADIOFREQUENCY LESIONBOSTON SCIENTIFIC NEUROMODULATION2020-03-09
PROBE, RADIOFREQUENCY LESIONBOSTON SCIENTIFIC NEUROMODULATION2020-03-09
REUSABLE ELECTRODE, 10CM, NITINOLMINTA MEDICAL LIMITED2020-02-24
REUSABLE ELECTRODE, 10CM, NITINOLMINTA MEDICAL LIMITED2020-02-24
DISPOSABLE SIMPLICITY ELECTRODEST. JUDE MEDICAL, INC.2020-02-20
UNKNOWN COOLED RF PROBES AND CANNULASAVANOS MEDICAL INC.2020-02-17
UNKNOWN COOLED RF PROBES AND CANNULASAVANOS MEDICAL INC.2020-02-17
UNKNOWN COOLED RF PROBES AND CANNULASAVANOS MEDICAL INC.2020-02-11
COOLIEF COOLED RADIOFREQUENCY PROBE KITAVANOS MEDICAL INC.2020-02-06
HALYARDHALYARD HEALTH, INC.2020-01-22
COOLIEF MULTI-COOLED RADIOFREQUENCY KITAVANOS MEDICAL INC.2019-12-27
REUSABLE ELECTRODE, 10CM, NITINOLMINTA MEDICAL LIMITED2019-11-22
COOLIEF* COOLED RADIOFREQUENCY KITAVANOS MEDICAL INC.2019-11-21
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19
NEUROTHERM? CLASSIC CURVED RF NEEDLE, 22G, 10CMST. JUDE MEDICAL, INC.2019-11-19

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