FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Carilex VT¿200-i NX
K Number: K231646
·
Decision Apr 17, 2024
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
3
Review Days
317
Basic Information
- Device Name
- Carilex VT¿200-i NX
- K Number
- K231646
- 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
- Carilex Medical, Inc.
- Date Received
- June 5, 2023
- Decision Date
- April 17, 2024
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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