PGW — Ear, Nose, And Throat Stereotaxic Instrument Class II
Classification Details
- Product Code
- PGW
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243053 | claronav | Navient Image Guided Navigation System (ENT) (955-NC-NC) | June 20, 2025 |
| K231862 | acclarent | TruDi® Navigation System V3 (FG-2000-00) | July 21, 2023 |
| K223734 | brainlab | ENT EM | April 27, 2023 |
| K221037 | acclarent | TruDi Shaver Blade | July 20, 2022 |
| K221098 | stryker corporation | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele | July 12, 2022 |
| K211291 | fiagon | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit | July 19, 2021 |
| K202609 | stryker corporation | Instrument Clamps Electromagnetic | October 9, 2020 |
| K201174 | acclarent | TruDi Curette | August 12, 2020 |
| K200723 | medtronic navigation | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | June 26, 2020 |
| K193453 | acclarent | TruDi Probe | March 23, 2020 |
| K200041 | fiagon | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | March 10, 2020 |
| K193118 | stryker ent | TGS Guidewire and updated Scopis Software | February 21, 2020 |
| K193502 | stryker ent | TGS Universal Headrest with Mounting Arm | February 14, 2020 |
| K192397 | biosense webster | TruDi Navigation System | January 30, 2020 |
| K190532 | acclarent | TruDi NAV Wire | May 3, 2019 |
| K180948 | acclarent | TruDi NAV Suction Instruments | July 20, 2018 |
| K173628 | acclarent | Acclarent ENT Navigation System | March 10, 2018 |
| K171661 | scopis | Scopis Extended Instrument Set EM | September 27, 2017 |
| K170018 | medtronic navigation | StealthStationTM S8 ENT Software | May 19, 2017 |
| K163416 | fiagon | Fiagon Navigation PointerTube Straight and PointerTube Keat | February 16, 2017 |