510(k) clearance

MONOFIX PDO

FDA 510(k) source

510(k) number

K253879

Applicant

Samyang Holdings Corporation

Decision date

Aug 25, 2026

Date received

Dec 4, 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

Daedeok-Gu, KR