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The Tracker / August 2026 / K253879

510(k) cleared

MONOFIX PDO

Samyang Holdings Corporation · Aug 25, 2026 · K253879

FDA cleared the MONOFIX PDO from Samyang Holdings Corporation on Aug 25, 2026 under K253879, a traditional 510(k). The device falls under product code NEW, Suture, Surgical, Absorbable, Polydioxanone, regulated at 21 CFR 878.4840 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 4, 2025. The decision came 264 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Samyang Holdings Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253879?

K253879 is the FDA 510(k) for MONOFIX PDO, submitted by Samyang Holdings Corporation. FDA's decision date was Aug 25, 2026, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the MONOFIX PDO?

Samyang Holdings Corporation, based in Daedeok-Gu, is the applicant of record for K253879.

How long did the K253879 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Aug 25, 2026, 264 days later.

← All decisions in August 2026