510(k) K233524

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) by Hollister Incorporated — Product Code EZD

K233524 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "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)". The FDA issued a decision of Substantially Equivalent on May 3, 2024. 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.