# K161344: GentleCath Glide Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Sep 20, 2016 after 130 days
- Product code: KOD (Catheter, Urological)
- 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: 2 generations back to K896750 (1990). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000070: Flocath, Rusch Intl. (2000) Summary page 5.
- K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter, Astra Tech, Inc. (2005) Summary page 5.

## Most influential descendants
- K181206: GentleCath Glide Intermittent Urinary Catheter (2018), 3 descendants of its own
- K232665: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (2024), 1 descendant of its own
- K213283: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (2022), 1 descendant of its own
- K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (2026), 0 descendants of its own

## Indications for use
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra. GentleCath Glide intermittent catheter is intended for adult use only.

Source page: https://510kreport.com/device/K161344
Methodology: https://510kreport.com/methodology