PointerShell LS
PointerShell LS is a reusable adapter that enables electromagnetic navigation of surgical instruments with octagonal shafts up to 6 mm in diameter. It is used with the Fiagon Navigation…
PointerShell LS is a reusable adapter that enables electromagnetic navigation of surgical instruments with octagonal shafts up to 6 mm in diameter. It is used with the Fiagon Navigation System in ENT procedures where rigid anatomy can be identified relative to CT or MR images.
A sensor within the adapter is tracked in the navigation system’s low-energy magnetic field. The software displays the position of the connected instrument in the preoperative images to assist the surgeon in locating anatomical structures.
Listed Item
The product PointerShell LS is a product variant for the navigation of shavers or surgical instruments without motor in the handle. The product PointerShell LS is used specially for the navigation surgical instruments with octagonal shafts with a maximum diameter of 6mm (For eg: Ostium Seeker produced by Entellus Medical Inc). The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic 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.
Instrument Connection and Preparation
The adapter mechanically connects to compatible shavers or surgical instruments without a motor in the handle. It is supplied nonsterile and requires sterilization by the user before reuse.
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) | K160479 |
| Record published | 2016-08-10 |
| Record revised | 2023-09-18 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 35 °C; Handling environment humidity 30 to 75 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2022-01-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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.