Cleared Traditional

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE

K010672 · Gramsmed, LLC · General & Plastic Surgery
May 2001
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K010672 is an FDA 510(k) clearance for the MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on May 18, 2001, 73 days after receiving the submission on March 6, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.

Submission Details

510(k) Number K010672 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2001
Decision Date May 18, 2001
Days to Decision 73 days
Submission Type Traditional
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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