About This 510(k) Submission
K212380 is an FDA 510(k) clearance for the PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on February 22, 2022, 204 days after receiving the submission on August 2, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.