Identity
- Trade Name
- FlexPointer 1.5 single use FDA UDI
- Generic Name
- ENT stereotactic surgery system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- E 01 3004 FDA UDI
- Primary DI / UDI-DI
- EFIAE0130041 FDA UDI
- 510(k) Number
- K200041 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- ENT stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENT stereotactic surgery system
FlexPointer 1.5 single use by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT stereotactic surgery system.
- StealthStation Cranial Software — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- Fusion™ ENT Image Guidance System — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation S8 — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation Cranial Software — MEDTRONIC NAVIGATION, INC. · Class II
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC. · Class II
- SteathStation — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K200041 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (1)
- FDA UDI d55873ac-77e9-435d-b103-15047b5e16af 35 fields · synced May 30, 2026