PGW · Ear, Nose, And Throat Stereotaxic Instrument
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | PGW |
|---|---|
| Device Name | Ear, Nose, And Throat Stereotaxic Instrument |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253395 | Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. | Mar 16, 2026 | SESE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | Jun 20, 2025 | SESE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | Jul 21, 2023 | SESE |
| K223734 | ENT EM | Brainlab AG | Apr 27, 2023 | SESE |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | Jul 20, 2022 | SESE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | Jul 12, 2022 | SESE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | Jul 19, 2021 | SESE |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | Oct 9, 2020 | SESE |
| K201174 | TruDi Curette | Acclarent, Inc. | Aug 12, 2020 | SESE |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | Jun 26, 2020 | SESE |
| K193453 | TruDi Probe | Acclarent, Inc. | Mar 23, 2020 | SESE |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | Mar 10, 2020 | SESE |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | Feb 21, 2020 | SESE |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | Feb 14, 2020 | SESE |
| K192397 | TruDi Navigation System | Biosense Webster | Jan 30, 2020 | SESE |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | May 3, 2019 | SESE |
| K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | Jul 20, 2018 | SESE |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | Mar 10, 2018 | SESE |
| K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | Sep 27, 2017 | SESE |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | May 19, 2017 | SESE |
Top Applicants
- Fiagon GmbH — 10 clearances
- Acclarent, Inc. — 8 clearances
- Medtronic Navigation, Inc. — 6 clearances
- Biosense Webster — 2 clearances
- Scopis GmbH — 2 clearances
