Identifiers
- 510(k) Number
- K251116 FDA 510(k)
- FDA Product Code
- EZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Luja Coude is an intermittent catheter designed for insertion into the urethra to reach the bladder, allowing for urine drainage. It is indicated for use by patients experiencing urine retention or post void residual volume due to neurogenic and non-neurogenic voiding dysfunction.
This device is intended for use by adult males, as well as male children aged 1 year and above. It is authorized under FDA 510k clearance and is classified as a class 2 medical device.
Frequently asked questions
What is the Luja Coudé catheter used for?
This device is an intermittent catheter designed for insertion into the urethra to reach the bladder. It is indicated for patients experiencing urine retention or post void residual volume resulting from neurogenic or non-neurogenic voiding dysfunction.
Who is the intended patient population for this catheter?
The Luja Coudé is intended for use by adult males, as well as male children aged 1 year and older, who require assistance with bladder drainage.
What is the regulatory status of the Luja Coudé?
The Luja Coudé is classified as a class 2 medical device and is authorized under FDA 510k clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Luja™ Coudé - Coloplast, Luja™ Coudé intermittent catheter for men - Coloplast, Luja Coudé - ColoplastCare, Luja™ Coudé - coloplastprofessional.us
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251116 | Class II | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K251116 24 fields · synced Sep 27, 2026