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510(k) K170827

INTRACEPT Intraosseous Nerve Ablation System by Relievant Medsystems — Product Code GXI

K170827 is an FDA 510(k) premarket notification submitted by Relievant Medsystems for the device "INTRACEPT Intraosseous Nerve Ablation System". The FDA issued a decision of Substantially Equivalent on August 9, 2017. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Relievant Medsystems has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2017
Date Received
March 20, 2017
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

Other clearances by Relievant Medsystems

  • K222281 — Intracept Intraosseous Nerve Ablation System (October 26, 2022)
  • K213836 — Intracept Intraosseous Nerve Ablation System (March 11, 2022)
  • K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous (May 3, 2019)
  • K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (September 14, 2018)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)
  • K153272 — INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (July 9, 2016)
  • K100641 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG001 (March 30, 2010)
  • K083856 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, (January 22, 2009)
  • K070443 — INTRACEPT BI-POLAR RF PROBE, MODEL 04814 (October 5, 2007)

Other clearances for product code GXI

  • K253907 — Disposable Radiofrequency Cannula (April 16, 2026)
  • K251802 — STAR RF Ablation System (February 13, 2026)
  • K251243 — OneRF Trigeminal Nerve Radiofrequency Probes (August 15, 2025)
  • K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (May 27, 2025)
  • K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBl (May 15, 2025)
  • 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)

FDA data resources