FDA cleared the MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture from ETHICON, Inc. on Feb 6, 2026 under K253852, a traditional 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Dec 2, 2025. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).
ETHICON, Inc. has 6 other decisions in the tracker over the last 12 months: K253394 (Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture), K252047 (STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices), K253572 (STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device), K252743 (STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device).