Cleared Traditional

K130191 - MINT

K130191 is an FDA 510(k) clearance for MINT, manufactured by Hans Biomed Corporation. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K130191 · Hans Biomed Corporation · General & Plastic Surgery device
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Jun 2013
Decision
138d
Days
Class 2
Risk

K130191 is an FDA 510(k) clearance for the MINT. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Hans Biomed Corporation (Brea, US). The FDA issued a Cleared decision on June 12, 2013 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K130191

510(k) Number K130191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date June 12, 2013
Days to Decision 138 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
23d slower than avg
Panel avg: 115d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

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 Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 64
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K130191.
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ORTHOCORD
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QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123877 · Surgical Specialties Corp. Dba Angiotech · Jan 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
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