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510(k) K050084

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; by Cosman Medical, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2005
Date Received
January 13, 2005
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 Cosman Medical, Inc.

  • K101131 — FIDUCIAL MARKERS (June 17, 2010)
  • K082051 — COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 (October 16, 2008)
  • K082012 — COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN (October 14, 2008)
  • K060799 — COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA (May 2, 2006)
  • K053415 — LESIONPOINT RF CANNULA (April 25, 2006)

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  • K241367 — RF Cannula (January 23, 2025)
  • K222281 — Intracept Intraosseous Nerve Ablation System (October 26, 2022)
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  • K203066 — COOLIEF Cooled Radiofrequency Kit Advanced (December 22, 2020)
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