About This 510(k) Submission
K233524 is an FDA 510(k) clearance for the Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized), a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on May 3, 2024, 184 days after receiving the submission on November 1, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.