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The Tracker / September 2026 / K254238

510(k) cleared

MINT MONO Sutures

Hans Biomed Corporation · Sep 18, 2026 · K254238

FDA cleared the MINT MONO Sutures from Hans Biomed Corporation on Sep 18, 2026 under K254238, 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 29, 2025. The decision came 263 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 Hans Biomed Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254238?

K254238 is the FDA 510(k) for MINT MONO Sutures, submitted by Hans Biomed Corporation. FDA's decision date was Sep 18, 2026, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the MINT MONO Sutures?

Hans Biomed Corporation, based in Yuseong-Gu, is the applicant of record for K254238.

How long did the K254238 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 18, 2026, 263 days later.

← All decisions in September 2026