Cleared Special

K181582 - DemeTECH DemeDIOX absorbable surgical s...

K181582 is the FDA 510(k) clearance for DemeTECH DemeDIOX absorbable surgical s... by Demetech Corporation. It is a Class 2 General & Plastic Surgery device (product code NEW) cleared through the Special 510(k) pathway after a 73-day FDA review.

K181582 · Demetech Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
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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 27
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