About This 510(k) Submission
K192580 is an FDA 510(k) clearance for the STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 18, 2019, 90 days after receiving the submission on September 19, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.