About This 510(k) Submission
K253852 is an FDA 510(k) clearance for the MONOCRYL? Plus Antibacterial Poliglecaprone ? 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on February 6, 2026, 66 days after receiving the submission on December 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.