K251414
- 510(k) number
- K251414
- Device name
- Miracu Polydioxanone (PDO) Suture and Needle (MONO)
- Applicant
- Feeltech Co., Ltd. KR
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2025-10-20
- Date received
- 2025-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251414.pdf
Official FDA record: K251414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.