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510(k) K232632

Racz Neurostat RF Generator by Epimed International — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
August 30, 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 Epimed International

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  • K072005 — RK EPIDURAL NEEDLE (February 7, 2008)
  • K053318 — RX EPIDURAL NEEDLE (February 17, 2006)
  • K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR (August 26, 2005)
  • K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (August 22, 2005)
  • K043467 — FLEXIBLE SPINAL NEEDLE (March 31, 2005)
  • K041021 — RF INTRODUCTION CANNULA (September 16, 2004)
  • K041843 — PENCIL POINT NEEDLE (August 24, 2004)

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  • 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)
  • K170242 — MultiGen™ 2 RF Generator System (May 25, 2017)