Fiagon Navigation PointerTube Straight and PointerTube Keat
FDA 510(k) K163416 · Fiagon GmbH
510(k) numberK163416
Submission
- Device name
- Fiagon Navigation PointerTube Straight and PointerTube Keat
- Applicant
- Fiagon GmbH
Hennigsdorf, DE - Received
- December 5, 2016
- Decision date
- February 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
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.
Other 510(k)s with product code PGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | Medtronic Xomed, Inc. | 09/04/2026SE |
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | Fiagon GmbH | 06/02/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | 06/02/2026SE |
| K230700 | RIWOtrack Navigation SystemOLO · Traditional | 11/20/2023SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | 05/26/2023SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | 07/19/2021SE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceLRC · Traditional | 08/26/2020SE |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW · Special | 03/10/2020SE |
| K163209 | Fiagon Navigation SystemHAW · Traditional | 09/14/2017SE |
| K162176 | Fiagon Navigation SystemPGW · Special | 12/01/2016SE |
| K161940 | Guidewire 0.6 Single UsePGW · Special | 09/18/2016SE |
| K151156 | Fiagon Navigation SystemHAW · Traditional | 04/01/2016SE |
Questions and answers
When was Fiagon Navigation PointerTube Straight and PointerTube Keat cleared by the FDA?
Fiagon Navigation PointerTube Straight and PointerTube Keat (K163416) received a 510(k) decision of Substantially Equivalent on February 16, 2017, 73 days after the submission was received.
What is the product code of K163416?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.