About This 510(k) Submission
K063603 is an FDA 510(k) clearance for the SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Suturtek Incorporated (Acton, US). The FDA issued a Cleared decision on February 7, 2007, 66 days after receiving the submission on December 3, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.