510(k) K253530

Trexon™ Monofilament Synthetic Absorbable Suture by Medtronic — Product Code GAM

K253530 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Trexon™ Monofilament Synthetic Absorbable Suture". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Medtronic has at least 10 other 510(k) clearances on record.