# K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Apr 1, 2026 after 198 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: 5 generations back to K896750 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213283: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter, Convatec Limited (2022) Summary page 5.
- K181206: GentleCath Glide Intermittent Urinary Catheter, Convatec Limited (2018) Summary page 5.
- K232665: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14), Convatec (2024) Summary page 5.

## Indications for use
GentleCath™ Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. GentleCath™ Air for Women: 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/K252943
Methodology: https://510kreport.com/methodology