Identity
- Trade Name
- NaviENT Accessory Kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- NaviENT Accessory Kit for use with the NaviENT surgical navigation system. FDA UDI
- Model / Reference
- 955-NE-ACCK FDA UDI
- Description
- NaviENT Accessory Kit for use with the NaviENT surgical navigation system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955105 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Neurological stereotactic surgery system
NaviENT Accessory Kit by ClaroNav Kolahi Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurological stereotactic surgery system.
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- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · 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 — 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 1533ce6c-71a5-49fe-a1c4-d12951e7162c 34 fields · synced May 30, 2026