About This 510(k) Submission
K153611 is an FDA 510(k) clearance for the Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Ethicon, LLC (Los Frailes Industrial Park, Suite 401, US). The FDA issued a Cleared decision on June 3, 2016, 169 days after receiving the submission on December 17, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.