Cleared Special

Infinity-Lock 3, Infinity-Lock 5

K171680 · Xiros, Ltd. · General & Plastic Surgery
Jun 2017
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K171680 is an FDA 510(k) clearance for the Infinity-Lock 3, Infinity-Lock 5, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on June 30, 2017, 24 days after receiving the submission on June 6, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K171680 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2017
Decision Date June 30, 2017
Days to Decision 24 days
Submission Type Special
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