FDA 510(k)

Modelo FP8 da Válvula de Glaucoma Ahmed®

Número K: K231051 · 2023-05-12

Data da decisão2023-05-12

Código do produtoKYF

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ahmed® Glaucoma Valve Model FP8 is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K231051. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ahmed® Glaucoma Valve Model FP8?

Ahmed® Glaucoma Valve Model FP8 is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is New World Medical, Inc.. The 510(k) number is K231051.

When did Ahmed® Glaucoma Valve Model FP8 receive FDA 510(k) clearance?

Ahmed® Glaucoma Valve Model FP8 received FDA 510(k) clearance on 2023-05-12, under 510(k) number K231051.

Who is the listed applicant for Ahmed® Glaucoma Valve Model FP8?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ahmed® Glaucoma Valve Model FP8?

The FDA product code for Ahmed® Glaucoma Valve Model FP8 is KYF.

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Outros registros que listam New World Medical, Inc. como candidato(a)

K243503VIA360™ Surgical System K220891Kahook Dual Blade Glide (KDB Glide)K230975Modelo FP7 da Válvula de Glaucoma Ahmed®K211680Sistema cirúrgico Streamline K182518Dispositivo de Drenagem de Glaucoma AHMED ClearPath K171451Modelo FP8 da Válvula de Glaucoma Ahmed

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Dispositivos Relacionados (Código: KYF)

K230975Modelo FP7 da Válvula de Glaucoma Ahmed®New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation K182518Dispositivo de Drenagem de Glaucoma AHMED ClearPathNew World Medical, Inc.K171451Modelo FP8 da Válvula de Glaucoma AhmedNew World Medical, Inc.K161457Sistema de Tratamento de Glaucoma XENAllergan, Inc.K162060Válvula de Glaucoma AhmedNew World Medical, Inc.

Fonte oficial

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