510(k) K261988

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture by Teleflex Medical, LLC — Product Code NEW

K261988 is an FDA 510(k) premarket notification submitted by Teleflex Medical, LLC for the device "Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture". The FDA issued a decision of Substantially Equivalent on July 9, 2026. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Teleflex Medical, LLC has at least 10 other 510(k) clearances on record.