FDA 510(k)

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

N.º K: K241028 · 2024-07-26

Fecha de decisión2024-07-26

Código de productoEZD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K241028. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Coloplast. The 510(k) number is K241028.

When did Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) receive FDA 510(k) clearance?

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K241028.

Who is the listed applicant for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

The FDA 510(k) record lists Coloplast as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)?

The FDA product code for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) is EZD.

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Otros registros que enlistan a Coloplast como solicitante

K231891Virtue Male Sling System with Alexis Wound Retractor Convenience Kit K230165Luja 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)K223821Self-Cath Closed System K221401Self-Cath and Self-Cath Plus K222059SpeediCath Flex Set K210250SpeedCath Compact Male

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Dispositivos relacionados (Código: EZD)

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Fuente oficial

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