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510(k) K200723

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) by Medtronic Navigation, Inc. — Product Code PGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2020
Date Received
March 19, 2020
Clearance Type
Traditional
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 Medtronic Navigation, Inc.

  • K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli (March 13, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K251282 — StealthStation S8 Spine Software (October 17, 2025)
  • K242464 — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (June 5, 2025)
  • K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422) (May 29, 2025)
  • K240465 — O-arm O2 Imaging System (June 21, 2024)
  • K231976 — StealthStation Cranial Software, v3.1.5 (9735585) (October 19, 2023)
  • K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (June 10, 2022)
  • K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4) (January 7, 2022)
  • K212397 — StealthStation S8 Cranial v2.0 (December 22, 2021)

Other clearances for product code PGW

  • K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC) (June 20, 2025)
  • K231862 — TruDi® Navigation System V3 (FG-2000-00) (July 21, 2023)
  • 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)
  • K193453 — TruDi Probe (March 23, 2020)
  • K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use (March 10, 2020)