FDA 510(k)

DR Safety Syringe, Sterile Hypodermic needle for Single use

Número K: K212226 · 2021-09-29

RequerenteZhuhai DR Medical Instruments Co., Ltd.

Data da decisão2021-09-29

Código do produtoMEG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

DR Safety Syringe, Sterile Hypodermic needle for Single use is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K212226. 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 DR Safety Syringe, Sterile Hypodermic needle for Single use?

DR Safety Syringe, Sterile Hypodermic needle for Single use is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Zhuhai DR Medical Instruments Co., Ltd.. The 510(k) number is K212226.

When did DR Safety Syringe, Sterile Hypodermic needle for Single use receive FDA 510(k) clearance?

DR Safety Syringe, Sterile Hypodermic needle for Single use received FDA 510(k) clearance on 2021-09-29, under 510(k) number K212226.

Who is the listed applicant for DR Safety Syringe, Sterile Hypodermic needle for Single use?

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

What is the FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use?

The FDA product code for DR Safety Syringe, Sterile Hypodermic needle for Single use is MEG.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Zhuhai DR Medical Instruments Co., Ltd. como candidato(a)

K251788Extension tube

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.