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510(k) K251243

OneRF Trigeminal Nerve Radiofrequency Probes by Neuroone Medical Technologies Corp. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
April 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

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Other clearances for product code GXI

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  • K241367 — RF Cannula (January 23, 2025)
  • K222281 — Intracept Intraosseous Nerve Ablation System (October 26, 2022)
  • K213836 — Intracept Intraosseous Nerve Ablation System (March 11, 2022)
  • K203066 — COOLIEF Cooled Radiofrequency Kit Advanced (December 22, 2020)
  • K190259 — Vesta RF Cannula (February 7, 2020)
  • K191293 — LCCS VC-S RF Cannula (January 24, 2020)
  • K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous (May 3, 2019)