Cleared Special

Aesculap Optilene Nonabsorbable Suture

K180321 · Aesculap, Inc. · General & Plastic Surgery
Mar 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K180321 is an FDA 510(k) clearance for the Aesculap Optilene Nonabsorbable Suture, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 7, 2018, 30 days after receiving the submission on February 5, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K180321 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2018
Decision Date March 07, 2018
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010