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510(k) K201472

VenSure Balloon Device, VenSure Nav Balloon Device by Fiagon GmbH — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
June 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Fiagon GmbH

  • K230700 — RIWOtrack Navigation System (November 20, 2023)
  • K230065 — VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSur (May 26, 2023)
  • K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit (July 19, 2021)
  • K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use (March 10, 2020)
  • K163209 — Fiagon Navigation System (September 14, 2017)
  • K163416 — Fiagon Navigation – PointerTube Straight and PointerTube Keat (February 16, 2017)
  • K162176 — Fiagon Navigation System (December 1, 2016)
  • K161940 — Guidewire 0.6 Single Use (September 18, 2016)
  • K151156 — Fiagon Navigation System (April 1, 2016)
  • K160479 — PointerShell Universal, PointerShell LS (March 23, 2016)

Other clearances for product code LRC

  • K230258 — BB 8 Sinus Dilation Kit (May 25, 2023)
  • K212774 — VenSure LightGuide (February 4, 2022)
  • K201398 — SINUSPRIME Dilation System (October 15, 2020)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K181546 — Dillard Nasal Balloon Catheter (January 3, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K181838 — Sinusway Dilation System (December 20, 2018)
  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)
  • K161698 — Relieva UltirraNav Sinus Balloon Catheter (October 24, 2016)