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510(k) K161491

Scopis Hybrid Navigation System EM by Scopis GmbH — Product Code PGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2017
Date Received
June 1, 2016
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 Scopis GmbH

  • K171661 — Scopis Extended Instrument Set EM (September 27, 2017)

Other clearances for product code PGW

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  • 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)
  • K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (June 26, 2020)
  • K193453 — TruDi Probe (March 23, 2020)