# K181206: GentleCath Glide Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Aug 16, 2018 after 101 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: 3 generations back to K896750 (1990). 4 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K161344: GentleCath Glide Intermittent Catheter, Convatec Limited (2016) Summary page 5.
- 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
- 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.

Source page: https://510kreport.com/device/K181206
Methodology: https://510kreport.com/methodology