510(k) K182873

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices by ETHICON, Inc. — Product Code NEW

K182873 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices". The FDA issued a decision of Substantially Equivalent on January 10, 2019. 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.