About This 510(k) Submission
K222944 is an FDA 510(k) clearance for the SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Safepath Medical, Inc. (Amesbury, US). The FDA issued a Cleared decision on October 18, 2024, 753 days after receiving the submission on September 26, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.