510(k) clearance
MINT MONO Sutures
- 510(k) number
- K254238
- Applicant
- Hans Biomed Corporation
- Decision date
- Sep 18, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NEW
- Device type
- Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II
- Regulation
- 21 CFR 878.4840
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Yuseong-Gu, KR