The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. The…
The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. 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.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for PointerShell 4 mm | 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) | K141456 |
| Record published | 2024-09-02 |
| Record revised | 2024-09-10 (version 9) |
Specifications
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 | 2024-09-10 |
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.