FDA 510(k)

Disposable Pen Injector Assembly

N.º K: K240961 · 2024-08-15

SolicitanteWuxi Nest Biotechnology Co., Ltd.

Fecha de decisión2024-08-15

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Pen Injector Assembly is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K240961. 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 Assembly?

Disposable Pen Injector Assembly is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K240961.

When did Disposable Pen Injector Assembly receive FDA 510(k) clearance?

Disposable Pen Injector Assembly received FDA 510(k) clearance on 2024-08-15, under 510(k) number K240961.

Who is the listed applicant for Disposable Pen Injector Assembly?

The FDA 510(k) record lists Wuxi Nest Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Pen Injector Assembly?

The FDA product code for Disposable Pen Injector Assembly is FMF.

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Otros registros que enlistan a Wuxi Nest Biotechnology Co., Ltd. como solicitante

K240774Pen Injector K211256Disposable Sampler Viral Transport Media K210440Disposable Sampler Inactivated Transport Media, Nest ITM

Dispositivos relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-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.

Fuente oficial

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