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FDA 510(k)

Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

N.º K: K253747 · 2026-08-14

SolicitanteJiangsu Enjosim Medical Technology Co., Ltd.
Fecha de decisión2026-08-14
Código de productoFMF
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Enjosim Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K253747. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Jiangsu Enjosim Medical Technology Co., Ltd.. The 510(k) number is K253747.

When did Disposable Pen Injector (KXYC-03C02, KXYC-03A03) receive FDA 510(k) clearance?

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K253747.

Who is the listed applicant for Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

The FDA 510(k) record lists Jiangsu Enjosim Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

The FDA product code for Disposable Pen Injector (KXYC-03C02, KXYC-03A03) is FMF.

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Dispositivos relacionados (Código: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.

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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