FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K Number: K230256
·
Decision Mar 3, 2023
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
35
Applicant Total
3
Review Days
31
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Basic Information
- Device Name
- Rebellion, Phantom Multi-Bite Kerrison Rongeur
- K Number
- K230256
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Morpheus AG
- Date Received
- January 31, 2023
- Decision Date
- March 3, 2023
- Product Code
- HAE
- 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
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