FDA 510(k) Applications for Medical Device Product Code "PGW"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K173628 | Acclarent, Inc | Acclarent ENT Navigation System | 03/10/2018 |
| K161697 | ACCLARENT, INC. | Acclarent NavWire Sinus Navigation Guidewire | 10/24/2016 |
| K201174 | Acclarent, Inc. | TruDi Curette | 08/12/2020 |
| K180948 | Acclarent, Inc. | TruDi NAV Suction Instruments | 07/20/2018 |
| K190532 | Acclarent, Inc. | TruDi NAV Wire | 05/03/2019 |
| K193453 | Acclarent, Inc. | TruDi Probe | 03/23/2020 |
| K221037 | Acclarent, Inc. | TruDi Shaver Blade | 07/20/2022 |
| K231862 | Acclarent, Inc. | TruDi« Navigation System V3 (FG-2000-00) | 07/21/2023 |
| K161701 | BIOSENSE WEBSTER | CARTO ENT System | 10/24/2016 |
| K192397 | Biosense Webster | TruDi Navigation System | 01/30/2020 |
| K223734 | Brainlab AG | ENT EM | 04/27/2023 |
| K211291 | Fiagon GmbH | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | 07/19/2021 |
| K133573 | FIAGON GMBH | FIAGON NAVIGATION SYSTEM | 04/30/2014 |
| K162176 | Fiagon GmbH | Fiagon Navigation System | 12/01/2016 |
| K163416 | FIAGON GMBH | Fiagon Navigation û PointerTube Straight and PointerTube Keat | 02/16/2017 |
| K150473 | FIAGON GMBH | FlexPointer 1.5 mm | 04/16/2015 |
| K200041 | Fiagon GmbH | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | 03/10/2020 |
| K160369 | FIAGON GMBH | GuideWire | 03/10/2016 |
| K161940 | FIAGON GMBH | Guidewire 0.6 Single Use | 09/18/2016 |
| K160479 | FIAGON GMBH | PointerShell Universal, PointerShell LS | 03/23/2016 |
| K141456 | FIAGON GMBH | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | 10/08/2014 |
| K161555 | KARL STORZ Endoscopy America, Inc. | KARL STORZ NAV1 Electromagnetic Navigation System | 10/21/2016 |
| K200723 | Medtronic Navigation Inc. | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | 06/26/2020 |
| K153555 | MEDTRONIC NAVIGATION, INC. | EM ENT Navigated Suctions | 04/07/2016 |
| K153247 | MEDTRONIC NAVIGATION, INC. | Fusion Compact Navigation System | 02/18/2016 |
| K133665 | MEDTRONIC NAVIGATION, INC. | MALLEABLE SUCTION INSTRUMENTS | 03/13/2014 |
| K170018 | Medtronic Navigation, Inc. | StealthStationTM S8 ENT Software | 05/19/2017 |
| K171661 | Scopis GmbH | Scopis Extended Instrument Set EM | 09/27/2017 |
| K161491 | Scopis GmbH | Scopis Hybrid Navigation System EM | 02/09/2017 |
| K141551 | STRYKER CORPORATE | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) | 09/08/2014 |
| K202609 | Stryker Corporation | Instrument Clamps Electromagnetic | 10/09/2020 |
| K221098 | Stryker Corporation | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | 07/12/2022 |
| K193118 | Stryker ENT | TGS Guidewire and updated Scopis Software | 02/21/2020 |
| K193502 | Stryker ENT | TGS Universal Headrest with Mounting Arm | 02/14/2020 |
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