Cleared Traditional

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

K190777 · Demetech Corporation · General & Plastic Surgery
Jul 2019
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K190777 is an FDA 510(k) clearance for the DemeTECH DemeFORCE Nonabsorbable Surgical Suture, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on July 31, 2019, 127 days after receiving the submission on March 26, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K190777 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2019
Decision Date July 31, 2019
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000