510(k) K192144

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device by ETHICON, Inc. — Product Code NEW

K192144 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device". The FDA issued a decision of Substantially Equivalent on March 25, 2020. 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.