Identity
- Trade Name
- NaviENT FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- NaviENT surgical navigation system FDA UDI
- Model / Reference
- 955-NE-NE FDA UDI
- Description
- NaviENT surgical navigation system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955099 FDA UDI
- 510(k) Number
- K163439 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Neurological 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
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
Category: Neurological stereotactic surgery systemENT stereotactic surgery system
NaviENT by ClaroNav Kolahi Inc — 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
- FlexPointer 1.5 single use — Fiagon GmbH · 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
Cleared under the same submission
K163439 also covers:
- Bayonet Probe — ClaroNav Kolahi Inc
- Bayonet Probe — ClaroNav Kolahi Inc
- C-Clamp Large — ClaroNav Kolahi Inc
- C-Clamp XL — ClaroNav Kolahi Inc
- C-Clamp medium — ClaroNav Kolahi Inc
- C-Clamp small — ClaroNav Kolahi Inc
- ENT Sterilization Tray — ClaroNav Kolahi Inc
- Frontal Seeker — ClaroNav Kolahi Inc
- Frontal Seeker B — ClaroNav Kolahi Inc
- Maxillary Seeker — ClaroNav Kolahi Inc
- Maxillary Seeker B — ClaroNav Kolahi Inc
- NaviENT Accessory Kit — ClaroNav Kolahi Inc
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
- ClaroNav Kolahi Inc
Sources (1)
- FDA UDI ef5a8016-84bf-4e41-b300-718943fd21d0 34 fields · synced Jun 8, 2026