FDA 510(k)

Pixie Skin Tag

Número K: K240226 · 2024-10-18

Data da decisão2024-10-18

Código do produtoORE

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pixie Skin Tag is the device name listed in this FDA 510(k) record. The listed applicant is Oystershell NV. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240226. The device is classified under product code ORE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pixie Skin Tag?

Pixie Skin Tag is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Oystershell NV. The 510(k) number is K240226.

When did Pixie Skin Tag receive FDA 510(k) clearance?

Pixie Skin Tag received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240226.

Who is the listed applicant for Pixie Skin Tag?

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

What is the FDA product code for Pixie Skin Tag?

The FDA product code for Pixie Skin Tag is ORE.

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