Identity
- Trade Name
- RegistrationPointer FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which is designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation system produced by Fiagon GmbH. The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation – Extended Instrument Set ENT 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 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 products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which is designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation system produced by Fiagon GmbH. The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation – Extended Instrument Set ENT 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 ENT surgery can be identified relative to a CT or MR based model of the anatomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFIAE0120031 FDA UDI
- 510(k) Number
- K141456 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
RegistrationPointer by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (1)
- FDA UDI 24f31124-f4fc-47d4-8e56-f99a43ba5a3c 37 fields · synced May 30, 2026