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FDA 510(k)

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe

N.º K: K211555 · 2021-10-18

SolicitanteAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Fecha de decisión2021-10-18
Código de productoMEG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K211555. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K211555.

When did Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe receive FDA 510(k) clearance?

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe received FDA 510(k) clearance on 2021-10-18, under 510(k) number K211555.

Who is the listed applicant for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe?

The FDA product code for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe is MEG.

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Otros registros que enlistan a Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. como solicitante

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.

K234024HWJECT Auto-disable syringeK230061Insulin SyringeK230043Insulin Pen NeedleK223323Blood Collection Needle (with/without Needle Holder)K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleK222141Safety Blood Collection Needle (Without Needle Holder)

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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