510(k) K253295

Coude Sleeved IC; Coude Plus Sleeved IC by Hollister Incorporated — Product Code EZD

K253295 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "Coude Sleeved IC; Coude Plus Sleeved IC". The FDA issued a decision of Substantially Equivalent on May 18, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Hollister Incorporated has at least 10 other 510(k) clearances on record.