Ear, Nose, And Throat Stereotaxic Instrument
The Ear, Nose, and Throat Stereotaxic Instrument is a surgical navigation device intended to precisely locate surgical instruments within anatomical structures during open or percutaneous ENT procedures, using CT- or MR-based imaging models or digitized anatomical landmarks as reference. It is an FDA Class 2 device regulated under 21 CFR 882.4560, requiring 510(k) clearance, classified under Neurology (NE) with ENT (EN) panel review. The product code is PGW. This device is not implantable and does not sustain life.
Research product code PGW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PGW
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 37 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Jun 02, 2026 | Substantially Equivalent | Fiagon GmbH |
| K253395 | Stealth AXiS ENT clinical application | Mar 16, 2026 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Jun 20, 2025 | Substantially Equivalent | Claronav |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Jul 21, 2023 | Substantially Equivalent | Acclarent, Inc. |
| K223734 | ENT EM | Apr 27, 2023 | Substantially Equivalent | Brainlab AG |
| K221037 | TruDi Shaver Blade | Jul 20, 2022 | Substantially Equivalent | Acclarent, Inc. |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Jul 12, 2022 | Substantially Equivalent | Stryker Corporation |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Jul 19, 2021 | Substantially Equivalent | Fiagon GmbH |
| K202609 | Instrument Clamps Electromagnetic | Oct 09, 2020 | Substantially Equivalent | Stryker Corporation |
| K201174 | TruDi Curette | Aug 12, 2020 | Substantially Equivalent | Acclarent, Inc. |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Jun 26, 2020 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K193453 | TruDi Probe | Mar 23, 2020 | Substantially Equivalent | Acclarent, Inc. |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Mar 10, 2020 | Substantially Equivalent | Fiagon GmbH |
| K193118 | TGS Guidewire and updated Scopis Software | Feb 21, 2020 | Substantially Equivalent | Stryker Ent |
| K193502 | TGS Universal Headrest with Mounting Arm | Feb 14, 2020 | Substantially Equivalent | Stryker Ent |
| K192397 | TruDi Navigation System | Jan 30, 2020 | Substantially Equivalent | Biosense Webster |
| K190532 | TruDi NAV Wire | May 03, 2019 | Substantially Equivalent | Acclarent, Inc. |
| K180948 | TruDi NAV Suction Instruments | Jul 20, 2018 | Substantially Equivalent | Acclarent, Inc. |
| K173628 | Acclarent ENT Navigation System | Mar 10, 2018 | Substantially Equivalent | Acclarent, Inc. |
| K171661 | Scopis Extended Instrument Set EM | Sep 27, 2017 | Substantially Equivalent | Scopis GmbH |
| K170018 | StealthStationTM S8 ENT Software | May 19, 2017 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | Feb 16, 2017 | Substantially Equivalent | Fiagon GmbH |
| K161491 | Scopis Hybrid Navigation System EM | Feb 09, 2017 | Substantially Equivalent | Scopis GmbH |
| K162176 | Fiagon Navigation System | Dec 01, 2016 | Substantially Equivalent | Fiagon GmbH |
| K161701 | CARTO ENT System | Oct 24, 2016 | Substantially Equivalent | Biosense Webster |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | Oct 24, 2016 | Substantially Equivalent | Acclarent, Inc. |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Oct 21, 2016 | Substantially Equivalent | Karl Storz Endoscopy America, Inc. |
| K161940 | Guidewire 0.6 Single Use | Sep 18, 2016 | Substantially Equivalent | Fiagon GmbH |
| K153555 | EM ENT Navigated Suctions | Apr 07, 2016 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K160479 | PointerShell Universal, PointerShell LS | Mar 23, 2016 | Substantially Equivalent | Fiagon GmbH |
| K160369 | GuideWire | Mar 10, 2016 | Substantially Equivalent | Fiagon GmbH |
| K153247 | Fusion Compact Navigation System | Feb 18, 2016 | Substantially Equivalent | Medtronic Navigation, Inc. |
| K150473 | FlexPointer 1.5 mm | Apr 16, 2015 | Substantially Equivalent | Fiagon GmbH |
| K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | Oct 08, 2014 | Substantially Equivalent | Fiagon GmbH |
| K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) | Sep 08, 2014 | Substantially Equivalent | Stryker Corporate |
| K133573 | FIAGON NAVIGATION SYSTEM | Apr 30, 2014 | Substantially Equivalent | Fiagon GmbH |
| K133665 | MALLEABLE SUCTION INSTRUMENTS | Mar 13, 2014 | Substantially Equivalent | Medtronic Navigation, Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.