Artelon Convenience Kits
FDA 510(k) clearance K260317 · decided 2026-04-09
Clearance details
- K-number
- K260317
- Device name
- Artelon Convenience Kits
- Applicant
- International Life Sciences
- Decision
- Substantially Equivalent
- Date received
- 2026-01-30
- Decision date
- 2026-04-09
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- QWJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sandy Springs, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.