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Probe, Radiofrequency Lesion

FDA product code GXI · Class 2 · Neurology

1,826
Registered devices
929
Adverse events
29
Recalls
66
510(k) clearances

Devices with this code

NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNeuroTherm™ — NEUROTHERM, INC.Epimed — EPIMED INTERNATIONAL, INCHalyard — Avanos Medical, Inc.OWL — Diros Technology IncNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONEpimed — EPIMED INTERNATIONAL, INCelectrodeCTC — COSMAN MEDICAL, LLCOWL — Diros Technology IncOWL — Diros Technology IncEpimed — MINTA MEDICAL LIMITEDOWL — Diros Technology IncEpimed — MINTA MEDICAL LIMITEDNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONOWL — Diros Technology InccannulaCC — COSMAN MEDICAL, LLCcannulaRFK — COSMAN MEDICAL, LLCOWL — Diros Technology IncNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONHalyard — Avanos Medical, Inc.NA — ST. JUDE MEDICAL, INC.electrodeEchoCUR — COSMAN MEDICAL, LLCRadiofrequency (RF) Needle — Spectra Medical Devices, LLCHalyard — Avanos Medical, Inc.

Recent recalls

DateFirmReason
2026-04-29Boston Scientific Neuromodulation CorporationReusable electrodes may not meet expected performance levels.
2026-04-29Boston Scientific Neuromodulation CorporationReusable electrodes may not meet expected performance levels.
2026-04-22Boston Scientific Neuromodulation CorporationIntraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if br
2024-06-03Stryker CorporationExpired Products distributed to customers
2020-06-08Medtronic Sofamor Danek USA IncInsertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08Medtronic Sofamor Danek USA IncInsertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08Medtronic Sofamor Danek USA IncInsertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08Medtronic Sofamor Danek USA IncInsertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08Medtronic Sofamor Danek USA IncInsertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-02-21Epimed InternationalIncorrect expiration date on introduction cannula packaging.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.