Cleared Special

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE

K050947 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery
Jun 2005
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K050947 is an FDA 510(k) clearance for the MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on June 1, 2005, 47 days after receiving the submission on April 15, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K050947 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2005
Decision Date June 01, 2005
Days to Decision 47 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010