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510(k) K000073

MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA by Mercury Medical — Product Code GXI

K000073 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA". The FDA issued a decision of Substantially Equivalent on March 1, 2000. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2000
Date Received
January 10, 2000
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 Mercury Medical

  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
  • K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (April 6, 2010)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • K083056 — NEO-STAT CO2 <KG (February 23, 2009)
  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
  • K031814 — STATCO2METER, MODEL 10-55372 (August 14, 2003)
  • K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (July 30, 2003)
  • K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (November 4, 2002)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
  • K970756 — MERCURY MEDICAL REUSABLE CPR BAG (October 31, 1997)

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