About This 510(k) Submission
K230746 is an FDA 510(k) clearance for the Non absorbable Surgical Polypropylene Suture, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Shandong Haidike Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on September 14, 2023, 181 days after receiving the submission on March 17, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.