Home / 510(k) Clearances / K231675

510(k) K231675

OneRF Ablation System by Neuroone Medical Technologies Corp. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2023
Date Received
June 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Neuroone Medical Technologies Corp.

  • K251243 — OneRF Trigeminal Nerve Radiofrequency Probes (August 15, 2025)
  • K222404 — Evo® sEEG System (October 20, 2022)
  • K211367 — Evo sEEG System (September 1, 2021)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV (August 14, 2024)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K181864 — Polaris RF Ablation System (January 2, 2019)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)
  • K170242 — MultiGen™ 2 RF Generator System (May 25, 2017)