About This 510(k) Submission
K252743 is an FDA 510(k) clearance for the STRATAFIX? Spiral PDS? Plus Knotless Tissue Control Device; STRATAFIX? Spiral MONOCRYL? Plus Knotless Tissue Control Device, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on December 22, 2025, 116 days after receiving the submission on August 28, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.