510(k) K251468

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) by Hollister Incorporated — Product Code EZD

K251468 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "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)". The FDA issued a decision of Substantially Equivalent on October 3, 2025. 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.