FDA 510(k)

Disposable Automatically Retractable Insulin Safety Syringe

N.º K: K210216 · 2022-03-04

SolicitanteShantou Wealy Medical Instrument Co.,Ltd

Fecha de decisión2022-03-04

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Automatically Retractable Insulin Safety Syringe 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 2022-03-04 under 510(k) number K210216. 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 Insulin Safety Syringe?

Disposable Automatically Retractable Insulin Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K210216.

When did Disposable Automatically Retractable Insulin Safety Syringe receive FDA 510(k) clearance?

Disposable Automatically Retractable Insulin Safety Syringe received FDA 510(k) clearance on 2022-03-04, under 510(k) number K210216.

Who is the listed applicant for Disposable Automatically Retractable Insulin Safety Syringe?

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 Insulin Safety Syringe?

The FDA product code for Disposable Automatically Retractable Insulin Safety Syringe is MEG.

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

K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)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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