About This 510(k) Submission
K182873 is an FDA 510(k) clearance for the 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, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 10, 2019, 90 days after receiving the submission on October 12, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.