Product code PGW
- Device name
- Ear, Nose, And Throat Stereotaxic Instrument
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | 2026-03-16 |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025-06-20 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023-07-21 |
| K223734 | ENT EM | Brainlab AG | 2023-04-27 |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | 2022-07-12 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | 2021-07-19 |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | 2020-10-09 |
| K201174 | TruDi Curette | Acclarent, Inc. | 2020-08-12 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | 2020-06-26 |
| K193453 | TruDi Probe | Acclarent, Inc. | 2020-03-23 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | 2020-03-10 |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020-02-21 |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | 2020-02-14 |
| K192397 | TruDi Navigation System | Biosense Webster | 2020-01-30 |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019-05-03 |
| K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018-07-20 |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018-03-10 |
| K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017-09-27 |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017-05-19 |
| K163416 | Fiagon Navigation – PointerTube Straight and PointerTube Keat | Fiagon GmbH | 2017-02-16 |
| K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | 2017-02-09 |
| K162176 | Fiagon Navigation System | Fiagon GmbH | 2016-12-01 |
| K161701 | CARTO ENT System | Biosense Webster | 2016-10-24 |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016-10-24 |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016-10-21 |
| K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016-09-18 |
| K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc. | 2016-04-07 |
| K160479 | PointerShell Universal, PointerShell LS | Fiagon GmbH | 2016-03-23 |
| K160369 | GuideWire | Fiagon GmbH | 2016-03-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150006427 | Stealth AXiS | MEDTRONIC NAVIGATION, INC. | 2026-04-24 |
| 00763000401191 | StealthStation S8 Platform | MEDTRONIC NAVIGATION, INC. | 2023-11-09 |
| 10705031469297 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 20705031469300 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 20705031469287 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 20705031469263 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 20705031469256 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 20705031469225 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 10705031469273 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 10705031469242 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 10705031469235 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 10705031469211 | TruDi Shaver Blade | ACCLARENT, INC. | 2022-09-09 |
| 10705031465596 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 10705031465572 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 10705031465565 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465586 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465616 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 10705031465428 | TruDi Curette | ACCLARENT, INC. | 2020-08-31 |
| 10705031464193 | TruDi Probe | ACCLARENT, INC. | 2020-07-31 |
| 10705031464209 | TruDi Probe | ACCLARENT, INC. | 2020-07-31 |
| 00763000238889 | StealthStation | MEDTRONIC NAVIGATION, INC. | 2020-06-27 |
| 10705031245907 | TruDi NAVWIRE | ACCLARENT, INC. | 2019-10-20 |
| 00763000238896 | StealthStation | MEDTRONIC NAVIGATION, INC. | 2019-05-20 |
| 10705031245853 | TruDi NAV Cable | ACCLARENT, INC. | 2018-10-31 |
| 10705031241015 | RELIEVA SPINPLUS NAV | ACCLARENT, INC. | 2018-02-18 |
| 10705031241008 | RELIEVA SPINPLUS NAV | ACCLARENT, INC. | 2018-02-09 |
| 00763000075163 | StealthStation | MEDTRONIC NAVIGATION, INC. | 2017-12-25 |
| 00643169839007 | StealthStation | MEDTRONIC NAVIGATION, INC. | 2017-08-12 |
| 00643169864658 | StealthStation | MEDTRONIC NAVIGATION, INC. | 2017-08-12 |
| 10705031237087 | ACCLARENT NAVWIRE | ACCLARENT, INC. | 2017-08-01 |