FDA 510(k)

Sterile Hypodermic Syringes for Single Use with Safety Needles

Número K: K221073 · 2022-10-04

RequerenteSichuan Prius Biotechnology Co., Ltd.

Data da decisão2022-10-04

Código do produtoMEG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Hypodermic Syringes for Single Use with Safety Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-04 under 510(k) number K221073. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Hypodermic Syringes for Single Use with Safety Needles?

Sterile Hypodermic Syringes for Single Use with Safety Needles is a medical device that received FDA 510(k) clearance on 2022-10-04. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221073.

When did Sterile Hypodermic Syringes for Single Use with Safety Needles receive FDA 510(k) clearance?

Sterile Hypodermic Syringes for Single Use with Safety Needles received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221073.

Who is the listed applicant for Sterile Hypodermic Syringes for Single Use with Safety Needles?

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

What is the FDA product code for Sterile Hypodermic Syringes for Single Use with Safety Needles?

The FDA product code for Sterile Hypodermic Syringes for Single Use with Safety Needles is MEG.

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Outros registros que listam Sichuan Prius Biotechnology Co., Ltd. como candidato(a)

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221075Infusion Sets for Single Use K221069Infusion Sets for Single Use with Needles K221080Sterile Safety Hypodermic Needles for Single Use K221066Sterile Hypodermic Needles for Single Use K221068Sterile Hypodermic Syringes for Single Use with Needles

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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

Fonte oficial

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