# K191633: Infyna Chic

- Pathway: 510(k) (Special)
- Applicant: Hollister Incorporated
- Decided: Jul 19, 2019 after 30 days
- Product code: GBM (Catheter, Urethral)
- 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: 7 generations back to K910022 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163179: Onli Intermittent Catheter, Hollister Incorporated (2017) Summary page 4.

## Most influential descendants
- K213575: Female IC (Not Finalized) (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K191633
Methodology: https://510kreport.com/methodology