Cleared Traditional

SERRALNYL

K020146 · Serral, S.A. DE C.V. · General & Plastic Surgery
Apr 2002
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K020146 is an FDA 510(k) clearance for the SERRALNYL, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on April 15, 2002, 89 days after receiving the submission on January 16, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.

Submission Details

510(k) Number K020146 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2002
Decision Date April 15, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAR — Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5020

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