# K232665: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

- Pathway: 510(k) (Traditional)
- Applicant: Convatec
- Decided: Jan 25, 2024 after 147 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: 4 generations back to K896750 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181206: GentleCath Glide Intermittent Urinary Catheter, Convatec Limited (2018) Summary page 5.

## Most influential descendants
- K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (2026), 0 descendants of its own

## Indications for use
Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

Source page: https://510kreport.com/device/K232665
Methodology: https://510kreport.com/methodology