510(k) K210871

PDO Max Suture with Dual Needle by Pdo Max, Inc. — Product Code NEW

K210871 is an FDA 510(k) premarket notification submitted by Pdo Max, Inc. for the device "PDO Max Suture with Dual Needle". The FDA issued a decision of Substantially Equivalent on December 17, 2021. 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.