About This 510(k) Submission
K230165 is an FDA 510(k) clearance for the Luja Coud? (20118 Male CH8 - small packaging (Pocket size)), Luja Coud? (20111 Male CH10 - small packaging (Pocket size)), Luja Coud? (20112 Male CH12 - small packaging (Pocket size)), Luja Coud? (20114 Male CH14 - small packaging (Pocket size)), Luja Coud? (20101 Male CH10 - large packaging), Luja Coud? (20102 Male CH12 - large packaging), Luja Coud? (20104 Male CH14 - large packaging), Luja Coud? (20106 Male CH16 - large packaging), a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on August 25, 2023, 217 days after receiving the submission on January 20, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.