PointerTube Keat
PointerTube Keat is an instrument used with the Fiagon Navigation system to help locate anatomical structures during open or percutaneous ENT surgery. Its indication requires a rigid…
PointerTube Keat is an instrument used with the Fiagon Navigation system to help locate anatomical structures during open or percutaneous ENT surgery. Its indication requires a rigid anatomical reference that can be identified relative to a CT or MR model of the patient’s anatomy.
A sensor in the instrument is tracked within the low-energy magnetic field generated by the navigation system. The navigation software displays the instrument’s position in the preoperative images, relating its location to the scanned anatomy during the procedure.
Listed Item
The product is a variant of a navigated suction instrument for image guided surgical procedures.The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Use Scope
The instrument is intended for ten uses. Example applications include intranasal, sinus, transsphenoidal access and skull-base procedures for ENT access, with navigation supplied by the compatible Fiagon system.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Fiagon GMBH, Germany |
|---|---|
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K163416 |
| Record published | 2025-01-16 |
| Record revised | 2025-01-23 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 15 to 35 °C |
| Sizes | Length 100 mm; outer diameter 3 mm |
| Distribution end date | 2025-01-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E012107 | In distribution | |
| 1 | Length 100 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | Karl Storz GmbH & Co. KG | 17 |
| StealthStation | Medtronic Navigation, Inc. | 17 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 14 |
| Ear, Nose, And Throat Stereotaxic Instrument | Medtronic Navigation, Inc. | 13 |
| Ear, Nose, And Throat Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 12 |
| StealthStation Cranial Software | Medtronic Navigation, Inc. | 11 |
| AxiEM™ | Medtronic Navigation, Inc. | 10 |
| Profess | Stryker Leibinger Gmbh & Co. KG | 8 |
| TGS | Stryker GmbH | 6 |
| StealthStation S8 | Medtronic Navigation, Inc. | 5 |
| TruDi Probe | Acclarent, Inc. | 4 |
| TruDi Shaver Blade | Acclarent, Inc. | 4 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261540 | 2026-06-02 |
| K211291 | 2021-07-19 |
| K200041 | 2020-03-10 |
| K163416 | 2017-02-16 |
| K162176 | 2016-12-01 |
| K161940 | 2016-09-18 |
| K160479 | 2016-03-23 |
| K160369 | 2016-03-10 |
| K150473 | 2015-04-16 |
| K141456 | 2014-10-08 |
| K133573 | 2014-04-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.