# K253295: Coude Sleeved IC; Coude Plus Sleeved IC

- Pathway: 510(k) (Traditional)
- Applicant: Hollister Incorporated
- Decided: May 18, 2026 after 231 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910022 (1991). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Hollister Incorporated (2024) Summary page 5.

## Indications for use
This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Source page: https://510kreport.com/device/K253295
Methodology: https://510kreport.com/methodology