FDA 510(k)

Sterile Syringe with Fixed Safety Needle for Single Use

N.º K: K212652 · 2022-03-02

SolicitanteGemtier Medical (Shanghai), Inc.

Fecha de decisión2022-03-02

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Syringe with Fixed Safety Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K212652. 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 Sterile Syringe with Fixed Safety Needle for Single Use?

Sterile Syringe with Fixed Safety Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K212652.

When did Sterile Syringe with Fixed Safety Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe with Fixed Safety Needle for Single Use received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212652.

Who is the listed applicant for Sterile Syringe with Fixed Safety Needle for Single Use?

The FDA 510(k) record lists Gemtier Medical (Shanghai), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use?

The FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use is MEG.

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Otros registros que enlistan a Gemtier Medical (Shanghai), Inc. como solicitante

K202493Medical Face Mask K202331Medical Face Mask K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use K170276Safety Blood Collection Device for Single Use

Dispositivos relacionados (Código: MEG)

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 Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject 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

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