Cleared Special

TroClose1200, TroClose1200 Cannula

K171494 · Gordian Surgical, Ltd. · General & Plastic Surgery
Jun 2017
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K171494 is an FDA 510(k) clearance for the TroClose1200, TroClose1200 Cannula, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Gordian Surgical, Ltd. (Misgav Business Park, IL). The FDA issued a Cleared decision on June 15, 2017, 24 days after receiving the submission on May 22, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.

Submission Details

510(k) Number K171494 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2017
Decision Date June 15, 2017
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4493

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