About This 510(k) Submission
K183183 is an FDA 510(k) clearance for the VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on June 27, 2019, 220 days after receiving the submission on November 19, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.