FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Dexter L6 System
K Number: K250435
·
Decision May 27, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- Dexter L6 System
- K Number
- K250435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4965
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Distalmotion SA
- Date Received
- February 14, 2025
- Decision Date
- May 27, 2025
- Product Code
- SDD
- 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 |
|---|---|---|---|
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SDD), ordered by most recent decision date.
Dexter L6 System
FDA 510(k)
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Dexter L6 System
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Dexter L6 System
FDA 510(k)
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