FDA 510(k)

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

Número K: K253747 · 2026-08-14

RequerenteJiangsu Enjosim Medical Technology Co., Ltd.

Data da decisão2026-08-14

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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