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510(k) K082051

COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 by Cosman Medical, Inc. — Product Code GXD

K082051 is an FDA 510(k) premarket notification submitted by Cosman Medical, Inc. for the device "COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4". The FDA issued a decision of Substantially Equivalent on October 16, 2008. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Cosman Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2008
Date Received
July 18, 2008
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 Cosman Medical, Inc.

  • K101131 — FIDUCIAL MARKERS (June 17, 2010)
  • 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)
  • K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; C (March 17, 2005)

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)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • 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)

FDA data resources