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FDA 510(k)

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

N.º K: K252098 · 2026-02-18

SolicitanteMethyl Co., Ltd.
Fecha de decisión2026-02-18
Código de productoMEG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is the device name listed in this FDA 510(k) record. The listed applicant is Methyl Co., Ltd.. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K252098. 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 PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Methyl Co., Ltd.. The 510(k) number is K252098.

When did PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) receive FDA 510(k) clearance?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) received FDA 510(k) clearance on 2026-02-18, under 510(k) number K252098.

Who is the listed applicant for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

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

What is the FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

The FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is MEG.

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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.

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Fuente oficial

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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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