FDA 510(k)

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization

N.º K: K220057 · 2022-10-07

SolicitanteShinva Ande Healthcare Apparatus Co., Ltd.

Fecha de decisión2022-10-07

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K220057. 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 Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K220057.

When did Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization receive FDA 510(k) clearance?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization received FDA 510(k) clearance on 2022-10-07, under 510(k) number K220057.

Who is the listed applicant for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

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

What is the FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

The FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is MEG.

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Otros registros que enlistan a Shinva Ande Healthcare Apparatus Co., Ltd. como solicitante

K201460Closed System Transfer Device K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles K202060Disposable IV catheter K193657Disposable Enteral Feeding Syringe with Enfit Connector K162601Infusion Set 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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