Cleared Special

WEGO-PGCL Absorbable Surgical Monofilament Suture

K142810 · Foosin Medical Supplies Inc., Ltd. · General & Plastic Surgery
Nov 2014
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K142810 is an FDA 510(k) clearance for the WEGO-PGCL Absorbable Surgical Monofilament Suture, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on November 14, 2014, 46 days after receiving the submission on September 29, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.

Submission Details

510(k) Number K142810 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2014
Decision Date November 14, 2014
Days to Decision 46 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

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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