FDA Device Intelligence
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Probe, Radiofrequency Lesion

FDA product code GXI · Class 2 · Neurology

1,809
Registered devices
897
Adverse events
29
Recalls
66
510(k) clearances

Devices with this code

Accurian — MEDTRONIC SOFAMOR DANEK, INC.Halyard — Avanos Medical, Inc.NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONOWL — Diros Technology IncOWL — Diros Technology IncAVANOS — Avanos Medical, Inc.NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONOWL — Diros Technology IncNeuroTherm™ — NEUROTHERM, INC.Halyard — Avanos Medical, Inc.NeuroTherm™ — NEUROTHERM, INC.OWL — Diros Technology IncRadiofrequency Single-Use Probe — Avanos Medical, Inc.cannulaEchoRF — COSMAN MEDICAL, LLCVesta — Stratus Medical LLCNA — STRYKER CORPORATIONEpimed — MINTA MEDICAL LIMITEDLCCS — LCCS Products LimitedRFTL — Pajunk GmbH MedizintechnologieOWL — Diros Technology InccannulaEchoRF — COSMAN MEDICAL, LLCOWL — Diros Technology IncNA — STRYKER CORPORATIONcannulaEchoRF — COSMAN MEDICAL, LLC

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.