Cleared Special

FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK

K100506 · Teleflex Medical · General & Plastic Surgery
Mar 2010
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K100506 is an FDA 510(k) clearance for the FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Teleflex Medical (Kenosha, US). The FDA issued a Cleared decision on March 10, 2010, 16 days after receiving the submission on February 22, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K100506 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2010
Decision Date March 10, 2010
Days to Decision 16 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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