FDA 510(k)

Disposable Automatically Retractable Safety Syringes (with detachable needle)

N.º K: K222452 · 2022-11-23

SolicitanteShantou Wealy Medical Instrument Co.,Ltd

Fecha de decisión2022-11-23

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Automatically Retractable Safety Syringes (with detachable needle) is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222452. 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 Disposable Automatically Retractable Safety Syringes (with detachable needle)?

Disposable Automatically Retractable Safety Syringes (with detachable needle) is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K222452.

When did Disposable Automatically Retractable Safety Syringes (with detachable needle) receive FDA 510(k) clearance?

Disposable Automatically Retractable Safety Syringes (with detachable needle) received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222452.

Who is the listed applicant for Disposable Automatically Retractable Safety Syringes (with detachable needle)?

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

What is the FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle)?

The FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle) is MEG.

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Otros registros que enlistan a Shantou Wealy Medical Instrument Co.,Ltd como solicitante

K210216Disposable Automatically Retractable Insulin Safety Syringe K203613ENFit Reusable Enteral Syringe K203410ENFit Disposable Enteral Syringe

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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