Cleared Traditional

K191361 - DemeDIOX Barbed Absorbable Surgical Suture

K191361 is the FDA 510(k) clearance for DemeDIOX Barbed Absorbable Surgical Suture by Demetech Corporation. It is a Class 2 General & Plastic Surgery device (product code NEW) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K191361 · Demetech Corporation · General & Plastic Surgery device
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Nov 2019
Decision
170d
Days
Class 2
Risk

K191361 is an FDA 510(k) clearance for the DemeDIOX Barbed Absorbable Surgical Suture. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on November 7, 2019 after a review of 170 days - an extended review cycle.

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 Demetech Corporation devices

Submission Details

510(k) Number K191361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2019
Decision Date November 07, 2019
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
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 Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 27
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K191361.
WEGO-PDO Barbed Suture
K201139 · Foosin Medical Supplies Inc., Ltd. · Oct 2020
MINT Product Family
K192423 · Hans Biomed Corporation · Sep 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · Ethicon, Inc. · Mar 2020
Viola
K190264 · Meditime Co., Ltd. · Aug 2019
PDS Barbed Suture, PDO MAXX Threads
K190245 · Pdo Max, Inc. · Jun 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
K182873 · Ethicon, Inc. · Jan 2019