Cleared Special

DemeTECH DemeDIOX absorbable surgical suture

K181582 · Demetech Corporation · General & Plastic Surgery
Aug 2018
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K181582 is an FDA 510(k) clearance for the DemeTECH DemeDIOX absorbable surgical suture, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on August 27, 2018, 73 days after receiving the submission on June 15, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.

Submission Details

510(k) Number K181582 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NEW — Suture, Surgical, Absorbable, Polydioxanone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4840

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