510(k) K190245

PDS Barbed Suture, PDO MAXX Threads by Pdo Max, Inc. — Product Code NEW

K190245 is an FDA 510(k) premarket notification submitted by Pdo Max, Inc. for the device "PDS Barbed Suture, PDO MAXX Threads". The FDA issued a decision of Substantially Equivalent on June 4, 2019. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Pdo Max, Inc. has at least 1 other 510(k) clearance on record.