510(k) K253852

MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture by ETHICON, Inc. — Product Code GAM

K253852 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture". The FDA issued a decision of Substantially Equivalent on February 6, 2026. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. ETHICON, Inc. has at least 10 other 510(k) clearances on record.