FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
Cary
K Number: K251111
·
Decision May 7, 2025
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
1
Review Days
26
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Basic Information
- Device Name
- Cary
- K Number
- K251111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Excitus AS
- Date Received
- April 11, 2025
- Decision Date
- May 7, 2025
- Product Code
- JCX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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