About This 510(k) Submission
K243897 is an FDA 510(k) clearance for the PDS? Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable 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 November 12, 2025, 328 days after receiving the submission on December 19, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.