Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → PGW — Ear, Nose, And Throat Stereotaxic Instrument # PGW · Ear, Nose, And Throat Stereotaxic Instrument _Neurology · 21 CFR 882.4560 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW ## Overview - **Product Code:** PGW - **Device Name:** Ear, Nose, And Throat Stereotaxic Instrument - **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253395](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K253395.md) | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | Mar 16, 2026 | SESE | | [K243053](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K243053.md) | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | Jun 20, 2025 | SESE | | [K231862](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K231862.md) | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | Jul 21, 2023 | SESE | | [K223734](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K223734.md) | ENT EM | Brainlab AG | Apr 27, 2023 | SESE | | [K221037](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K221037.md) | TruDi Shaver Blade | Acclarent, Inc. | Jul 20, 2022 | SESE | | [K221098](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K221098.md) | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | Jul 12, 2022 | SESE | | [K211291](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K211291.md) | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | Jul 19, 2021 | SESE | | [K202609](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K202609.md) | Instrument Clamps Electromagnetic | Stryker Corporation | Oct 9, 2020 | SESE | | [K201174](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K201174.md) | TruDi Curette | Acclarent, Inc. | Aug 12, 2020 | SESE | | [K200723](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K200723.md) | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | Jun 26, 2020 | SESE | | [K193453](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K193453.md) | TruDi Probe | Acclarent, Inc. | Mar 23, 2020 | SESE | | [K200041](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K200041.md) | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | Mar 10, 2020 | SESE | | [K193118](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K193118.md) | TGS Guidewire and updated Scopis Software | Stryker Ent | Feb 21, 2020 | SESE | | [K193502](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K193502.md) | TGS Universal Headrest with Mounting Arm | Stryker Ent | Feb 14, 2020 | SESE | | [K192397](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K192397.md) | TruDi Navigation System | Biosense Webster | Jan 30, 2020 | SESE | | [K190532](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K190532.md) | TruDi NAV Wire | Acclarent, Inc. | May 3, 2019 | SESE | | [K180948](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K180948.md) | TruDi NAV Suction Instruments | Acclarent, Inc. | Jul 20, 2018 | SESE | | [K173628](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K173628.md) | Acclarent ENT Navigation System | Acclarent, Inc. | Mar 10, 2018 | SESE | | [K171661](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K171661.md) | Scopis Extended Instrument Set EM | Scopis GmbH | Sep 27, 2017 | SESE | | [K170018](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW/K170018.md) | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | May 19, 2017 | SESE | ## Top Applicants - Fiagon GmbH — 10 clearances - Acclarent, Inc. — 8 clearances - Medtronic Navigation, Inc. — 6 clearances - Biosense Webster — 2 clearances - Scopis GmbH — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PGW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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