Cleared Traditional

MINT Product Family (K192423) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192423 · Hans Biomed Corporation · General & Plastic Surgery device
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Sep 2020
Decision
371d
Days
Class 2
Risk

K192423 is an FDA 510(k) clearance for the MINT Product Family. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Hans Biomed Corporation (Seoul, KR). The FDA issued a Cleared decision on September 9, 2020 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hans Biomed Corporation devices

Submission Details

510(k) Number K192423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date September 09, 2020
Days to Decision 371 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 115d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Emergo Global Consulting, LLC
Michael Dun

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 26
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K192423.
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380 · Ethicon, Inc. · Feb 2022
PDO Max Suture with Dual Needle
K210871 · Pdo Max, Inc. · Dec 2021
WEGO-PDO Barbed Suture
K201139 · Foosin Medical Supplies Inc., Ltd. · Oct 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · Ethicon, Inc. · Mar 2020
DemeDIOX Barbed Absorbable Surgical Suture
K191361 · Demetech Corporation · Nov 2019
Viola
K190264 · Meditime Co., Ltd. · Aug 2019