FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Digital ClarusScope System, Digital NeuroPEN System
K Number: K223615
·
Decision Nov 21, 2023
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
90
Applicant Total
3
Review Days
351
Basic Information
- Device Name
- Digital ClarusScope System, Digital NeuroPEN System
- K Number
- K223615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarus Medical, LLC
- Date Received
- December 5, 2022
- Decision Date
- November 21, 2023
- Product Code
- GWG
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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