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FDA 510(k)

Self-Cath and Self-Cath Plus

N.º K: K221401 · 2022-12-02

SolicitanteColoplast
Fecha de decisión2022-12-02
Código de productoEZD
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Self-Cath and Self-Cath Plus is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221401. 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 Self-Cath and Self-Cath Plus?

Self-Cath and Self-Cath Plus is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Coloplast. The 510(k) number is K221401.

When did Self-Cath and Self-Cath Plus receive FDA 510(k) clearance?

Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221401.

Who is the listed applicant for Self-Cath and Self-Cath Plus?

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 Self-Cath and Self-Cath Plus?

The FDA product code for Self-Cath and Self-Cath Plus is EZD.

Otros registros que enlistan a Coloplast como solicitante

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K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitK230165Luja 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 SystemK222059SpeediCath Flex SetK210250SpeedCath Compact Male

Ver todos los 15 dispositivos →

Dispositivos relacionados (Código: EZD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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