# K213575: Female IC (Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Hollister Incorporated
- Decided: Sep 13, 2022 after 307 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: 8 generations back to K910022 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191633: Infyna Chic, Hollister Incorporated (2019) Summary page 4.

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

Source page: https://510kreport.com/device/K213575
Methodology: https://510kreport.com/methodology