About This 510(k) Submission
K234107 is an FDA 510(k) clearance for the Solar? Anorectal Manometry Catheter (Model Number: K1210AC-L-2212), a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA), submitted by Laborie Medical Technologies, Corp. (Portsmouth, US). The FDA issued a Cleared decision on April 23, 2024, 119 days after receiving the submission on December 26, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.