Suture-TOOL System
FDA 510(k) clearance K242835 · decided 2025-01-22
Clearance details
- K-number
- K242835
- Device name
- Suture-TOOL System
- Applicant
- Suturion AB
- Decision
- Substantially Equivalent
- Date received
- 2024-09-19
- Decision date
- 2025-01-22
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.