PGW — Ear, Nose, And Throat Stereotaxic Instrument Class II
FDA product code PGW covers "Ear, Nose, And Throat Stereotaxic Instrument", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261540 | fiagon | Cube 4D Navigation System, VirtuEye Pro | June 2, 2026 |
| K253395 | medtronic navigation | Stealth AXiS ENT clinical application | March 16, 2026 |
| 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 |