510(k) K212380

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture by ETHICON, Inc. — Product Code NEW

K212380 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture". The FDA issued a decision of Substantially Equivalent on February 22, 2022. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. ETHICON, Inc. has at least 10 other 510(k) clearances on record.