About This 510(k) Submission
K251468 is an FDA 510(k) clearance for the Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A), a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on October 3, 2025, 143 days after receiving the submission on May 13, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.