The products FlexPointer 1.5 Cranial is a product variant of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system.…
The products FlexPointer 1.5 Cranial is a product variant of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system. The Navigation system is 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for FlexPointer 1.5 Cranial | Listed by | Fiagon GMBH, Germany |
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K151156 |
| Record published | 2020-03-27 |
| Record revised | 2023-09-18 (version 6) |
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 | 2024-09-05 |
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.