FDA 510(k)

Sterile Auto-Disable Syringes with/without Needle for Single Use

N.º K: K210229 · 2022-02-15

SolicitanteZhejiang Kangkang Medical-Devices Co., Ltd.

Fecha de decisión2022-02-15

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) number K210229. 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 Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210229.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-02-15, under 510(k) number K210229.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA 510(k) record lists Zhejiang Kangkang Medical-Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is MEG.

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Otros registros que enlistan a Zhejiang Kangkang Medical-Devices Co., Ltd. como solicitante

K213535Sterile Safety Hypodermic Needles for Single Use K210232Sterile Hypodermic Needles for Single Use K210227Sterile syringe for single use with/without needle

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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