Cleared Traditional

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

K153076 · Teleflexmedical, Inc. · General & Plastic Surgery
Jun 2016
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K153076 is an FDA 510(k) clearance for the silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on June 16, 2016, 237 days after receiving the submission on October 23, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K153076 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2015
Decision Date June 16, 2016
Days to Decision 237 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