FDA 510(k)

Sterile Hypodermic Syringe for Single Use

N.º K: K212207 · 2023-03-23

SolicitanteShandong Weigao Group Medical Polymer Co., Ltd.

Fecha de decisión2023-03-23

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Hypodermic Syringe for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K212207. 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 Sterile Hypodermic Syringe for Single Use?

Sterile Hypodermic Syringe for Single Use is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. The 510(k) number is K212207.

When did Sterile Hypodermic Syringe for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use received FDA 510(k) clearance on 2023-03-23, under 510(k) number K212207.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use?

The FDA 510(k) record lists Shandong Weigao Group Medical Polymer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringe for Single Use?

The FDA product code for Sterile Hypodermic Syringe for Single Use is FMF.

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Otros registros que enlistan a Shandong Weigao Group Medical Polymer Co., Ltd. como solicitante

K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

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

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.