# K172924: GentleCath Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Nov 21, 2017 after 57 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: 3 generations back to K003784 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140953: Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter, Convatec, Ltd. (2014) Summary page 5.
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 5.

## Indications for use
Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

Source page: https://510kreport.com/device/K172924
Methodology: https://510kreport.com/methodology