Cleared Special

DemeTECH DemeDIOX absorbable surgical suture (K181582) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181582 · Demetech Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
73d
Days
Class 2
Risk

K181582 is an FDA 510(k) clearance for the DemeTECH DemeDIOX 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 August 27, 2018 after a review of 73 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Demetech Corporation devices

Submission Details

510(k) Number K181582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2018
Decision Date August 27, 2018
Days to Decision 73 days
Submission Type Special
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
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K181582.
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
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K250107 · Feeltech Co., Ltd. · Oct 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · M/s. Meril Endo Surgery Private Limited. · Sep 2025
Suture-TOOL System
K250977 · Suturion AB · Apr 2025