FDA 510(k)

FlashHeal 2 (FlashHeal 2.0)

Número K: K233077 · 2024-01-18

Data da decisão2024-01-18

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FlashHeal 2 (FlashHeal 2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Inwound Aps. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K233077. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FlashHeal 2 (FlashHeal 2.0)?

FlashHeal 2 (FlashHeal 2.0) is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Inwound Aps. The 510(k) number is K233077.

When did FlashHeal 2 (FlashHeal 2.0) receive FDA 510(k) clearance?

FlashHeal 2 (FlashHeal 2.0) received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233077.

Who is the listed applicant for FlashHeal 2 (FlashHeal 2.0)?

The FDA 510(k) record lists Inwound Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlashHeal 2 (FlashHeal 2.0)?

The FDA product code for FlashHeal 2 (FlashHeal 2.0) is GEX. This falls under the Gastroenterology category.

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