The decision, classifying the device under General and Plastic Surgery, marks a regulatory step for the Korean manufacturer's absorbable sutures in the U.S. market.
Hans Biomed Corporation has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MINT MONO Sutures. The decision, issued on September 18, 2026, classifies the device as substantially equivalent for use within the General and Plastic Surgery advisory committee domain.
The K254238 clearance designates MINT MONO Sutures as a Class II device under regulation number 878.4840, pertaining to non-absorbable synthetic surgical sutures. This Traditional 510(k) pathway indicates the device's equivalence to a predicate device already on the market.
Device Overview
The MINT MONO Sutures are absorbable synthetic surgical sutures, a common category of medical devices utilized in various surgical specialties. The specific formulation and design characteristics of MINT MONO Sutures have not been publicly detailed beyond their general classification as mono-filament type sutures.
As an absorbable suture, the material is designed to degrade and be absorbed by the body over time, eliminating the need for removal. This characteristic is often preferred in aesthetic procedures where minimizing patient visits and reducing the risk of visible foreign material are considerations.
Regulatory Implications
This 510(k) clearance enables Hans Biomed to market and distribute MINT MONO Sutures in the United States. The K254238 clearance is based on a Summary rather than a full 510(k) Statement, indicating that detailed performance data and substantial equivalence arguments are on file with the FDA but not fully public. The specific intended use and indications for MINT MONO Sutures, beyond the general 'General and Plastic Surgery' committee, have not been disclosed by the company or detailed in the public FDA record at the time of this report.
The clearance allows for market entry but specific clinical claims or comparative performance data remain to be publicly detailed.
Hans Biomed Corporation, a South Korean medical device manufacturer, has a portfolio that includes various biomaterials and medical aesthetics products. This clearance adds a new absorbable suture product to their U.S. market offerings.
