FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ClearPointer Optical Navigation Wand
K Number: K233155
·
Decision Jan 12, 2024
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
12
Review Days
107
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Basic Information
- Device Name
- ClearPointer Optical Navigation Wand
- K Number
- K233155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ClearPoint Neuro, Inc.
- Date Received
- September 27, 2023
- Decision Date
- January 12, 2024
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
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| K233243 | ClearPoint System (Software Version 2.2) | Nov 27, 2023 | Substantially Equivalent |
| K232102 | ClearPoint Array System (Version 1.2) | Sep 15, 2023 | Substantially Equivalent |
| K222519 | ClearPoint System | Sep 16, 2022 | Substantially Equivalent |
| K213645 | ClearPoint Maestro Brain Model | Aug 8, 2022 | Substantially Equivalent |
| K214040 | ClearPoint Array System (version 1.1) | Apr 12, 2022 | Substantially Equivalent |