# K140953: Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Ltd.
- Decided: Aug 1, 2014 after 109 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 K003784 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896729: Nelaton-, Female - or Tiemann Catheter, Unoplast A/S (1990) Summary page 5.
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 5.

## Most influential descendants
- K172924: GentleCath Intermittent Urinary Catheter (2017), 0 descendants of its own

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

Source page: https://510kreport.com/device/K140953
Methodology: https://510kreport.com/methodology