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510(k) K231862

TruDi® Navigation System V3 (FG-2000-00) by Acclarent, Inc. — Product Code PGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
June 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ear, Nose, And Throat Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
EN
Submission Type

Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Other clearances by Acclarent, Inc.

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K183090 — Relieva Tract Balloon Dilation System (April 19, 2019)
  • K180948 — TruDi NAV Suction Instruments (July 20, 2018)

Other clearances for product code PGW

  • K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC) (June 20, 2025)
  • K223734 — ENT EM (April 27, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele (July 12, 2022)
  • K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit (July 19, 2021)
  • K202609 — Instrument Clamps Electromagnetic (October 9, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (June 26, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use (March 10, 2020)