FDA Product Code
FDA Product Code PGW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | Medtronic Xomed, Inc. | 2026-09-04 | Traditional | PDF ↗ |
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | 2026-06-02 | Special | PDF ↗ |
| K253395 | Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. | 2026-03-16 | Traditional | PDF ↗ |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025-06-20 | Traditional | PDF ↗ |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023-07-21 | Special | PDF ↗ |
| K223734 | ENT EM | Brainlab AG | 2023-04-27 | Traditional | PDF ↗ |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 | Traditional | PDF ↗ |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | 2022-07-12 | Traditional | PDF ↗ |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | 2021-07-19 | Traditional | PDF ↗ |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | 2020-10-09 | Special | PDF ↗ |
| K201174 | TruDi Curette | Acclarent, Inc. | 2020-08-12 | Traditional | PDF ↗ |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K193453 | TruDi Probe | Acclarent, Inc. | 2020-03-23 | Traditional | PDF ↗ |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | 2020-03-10 | Special | PDF ↗ |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020-02-21 | Traditional | PDF ↗ |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | 2020-02-14 | Traditional | PDF ↗ |
| K192397 | TruDi Navigation System | Biosense Webster | 2020-01-30 | Traditional | PDF ↗ |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019-05-03 | Traditional | PDF ↗ |
| K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018-07-20 | Traditional | PDF ↗ |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018-03-10 | Special | PDF ↗ |
| K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017-09-27 | Traditional | PDF ↗ |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube Keat | Fiagon GmbH | 2017-02-16 | Special | PDF ↗ |
| K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | 2017-02-09 | Traditional | PDF ↗ |
| K162176 | Fiagon Navigation System | Fiagon GmbH | 2016-12-01 | Special | PDF ↗ |
| K161701 | CARTO ENT System | Biosense Webster | 2016-10-24 | Traditional | PDF ↗ |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016-10-24 | Traditional | PDF ↗ |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016-09-18 | Special | PDF ↗ |
| K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc. | 2016-04-07 | Traditional | PDF ↗ |
| K160479 | PointerShell Universal, PointerShell LS | Fiagon GmbH | 2016-03-23 | Special | PDF ↗ |
| K160369 | GuideWire | Fiagon GmbH | 2016-03-10 | Special | PDF ↗ |
| K153247 | Fusion Compact Navigation System | Medtronic Navigation, Inc. | 2016-02-18 | Traditional | PDF ↗ |
| K150473 | FlexPointer 1.5 mm | Fiagon GmbH | 2015-04-16 | Special | PDF ↗ |
| K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL | Fiagon GmbH | 2014-10-08 | Traditional | PDF ↗ |
| K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) | Stryker Corporate | 2014-09-08 | Traditional | PDF ↗ |
| K133573 | FIAGON NAVIGATION SYSTEM | Fiagon GmbH | 2014-04-30 | Traditional | PDF ↗ |
| K133665 | MALLEABLE SUCTION INSTRUMENTS | Medtronic Navigation, Inc. | 2014-03-13 | Traditional | PDF ↗ |
Product code PGW · Class II · Neurology. Data: openFDA.