FlexPointer 1.5 Single Use
FlexPointer 1.5 single use is a malleable pointing probe for electromagnetic surgical navigation with the Fiagon Navigation system. A sensor inside the tip lets the system display the…
FlexPointer 1.5 single use is a malleable pointing probe for electromagnetic surgical navigation with the Fiagon Navigation system. A sensor inside the tip lets the system display the instrument’s position relative to preoperative anatomical images.
The probe helps locate rigid anatomical structures in open or percutaneous ENT procedures where anatomy can be referenced to a CT- or MR-based model. Examples include sinus, intranasal and selected anterior skull-base procedures.
Listed Item
The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for 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.
Supply and Connection
The instrument is supplied sterile as a disposable single-use device. Its sensor is tracked within the navigation generator’s low-energy magnetic field. The connector housing uses polysulfone and retains the navigation-system plug interface.
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) | K200041 |
| Record published | 2021-06-11 |
| Record revised | 2022-10-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 20, pack of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
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.