Identity
- Trade Name
- ClearPoint Array Workstation FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- ClearPoint Array v1.x Neuro Workstation FDA UDI
- Model / Reference
- CPA-WK-01 FDA UDI
- Description
- ClearPoint Array v1.x Neuro Workstation FDA UDI
Identifiers
- Catalog Number
- CPA-WK-01 FDA UDI
- Primary DI / UDI-DI
- 00850359007911 FDA UDI
- 510(k) Number
- K202575 FDA UDI
- FDA Product Code
- HAW 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Neurological stereotactic surgery system
ClearPoint Array Workstation by Clearpoint Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202575 also covers:
- Array — Clearpoint Neuro, Inc.
- Array — Clearpoint Neuro, Inc.
- Array — Clearpoint Neuro, Inc.
- Array — Clearpoint Neuro, Inc.
- ClearPoint Array — Clearpoint Neuro, Inc.
- SMARTFrame Array — Clearpoint Neuro, Inc.
- SmartFrame Array — Clearpoint Neuro, Inc.
- SmartFrame Array — Clearpoint Neuro, Inc.
- SmartFrame Array — Clearpoint Neuro, Inc.
- SmartFrame Array — Clearpoint Neuro, 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
- Clearpoint Neuro, Inc.
Sources (1)
- FDA UDI eb47a19c-b05b-4244-9980-1b80343309c1 36 fields · synced May 30, 2026