FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Artelon Convenience Kits
K Number: K260317
·
Decision Apr 9, 2026
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
4
Review Days
69
Basic Information
- Device Name
- Artelon Convenience Kits
- K Number
- K260317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Life Sciences
- Date Received
- January 30, 2026
- Decision Date
- April 9, 2026
- Product Code
- QWJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| QWJ | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | FDA class 2 | General, Plastic Surgery |