About This 510(k) Submission
K120284 is an FDA 510(k) clearance for the DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on May 23, 2012, 113 days after receiving the submission on January 31, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.