Identity
- Trade Name
- RegistrationPointer Cranial FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The RegistrationPointert Cranial 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 instrument is 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The RegistrationPointert Cranial 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 instrument is 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFIAE012003CUS1 FDA UDI
- 510(k) Number
- K151156 FDA UDI
- FDA Product Code
- HAW 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 Cranial by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151156 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (1)
- FDA UDI 10da3ab6-1bc1-44c7-8b2c-e1cf3dc59ad5 37 fields · synced Jun 1, 2026