K233101
- 510(k) number
- K233101
- Device name
- Luja Coude (20108 Male CH18 - large packaging)
- Applicant
- Coloplast Corp. MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2023-10-26
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K233101.pdf
Official FDA record: K233101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.