# K230165: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé  (20101 Male CH10 - large packaging), Luja Coudé  (20102 Male CH12 - large packaging), Luja Coudé  (20104 Male CH14 - large packaging), Luja Coudé  (20106 Male CH16 - large packaging)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Aug 25, 2023 after 217 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: 6 generations back to K910022 (1991). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190620: SpeediCath Flex Coude Pro, Coloplast (2019) Summary page 5.

## Most influential descendants
- K241210: Luja Coude (2024), 2 descendants of its own
- K251116: Luja Coudé (2025), 0 descendants of its own
- K250270: Luja Set (2025), 0 descendants of its own
- K233101: Luja Coude (20108 Male CH18 - large packaging) (2023), 0 descendants of its own

## Indications for use
Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for adult male patients only.

Source page: https://510kreport.com/device/K230165
Methodology: https://510kreport.com/methodology