FDA 510(k)

Blue Eye

Número K: K241591 · 2024-07-03

Data da decisão2024-07-03

Código do produtoPLL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Eye is the device name listed in this FDA 510(k) record. The listed applicant is The Standard Co., Ltd.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K241591. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blue Eye?

Blue Eye is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is The Standard Co., Ltd.. The 510(k) number is K241591.

When did Blue Eye receive FDA 510(k) clearance?

Blue Eye received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241591.

Who is the listed applicant for Blue Eye?

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

What is the FDA product code for Blue Eye?

The FDA product code for Blue Eye is PLL.

Outros registros que listam The Standard Co., Ltd. como candidato(a)

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.

K220434Blue Eye (TS-905)

Dispositivos Relacionados (Código: PLL)

K260997SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)Endoclot Plus Co., Ltd.K220434Blue Eye (TS-905)The Standard Co., Ltd.K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.K202376EverLift Submucosal Lifting AgentGi Supply, Inc.K191923EverLift Submucosal Lifting AgentGi Supply

Fonte oficial

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