About This 510(k) Submission
K233079 is an FDA 510(k) clearance for the Zimmon? Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen? Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin? Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen? Sof-Flex? Pancreatic Stent (GPSO-SF. GPSOS-SF), a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on June 14, 2024, 262 days after receiving the submission on September 26, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.