FDA 510(k)

Epi-Stop Nasal Gel/epistaxis pack

Número K: K230142 · 2023-03-22

Data da decisão2023-03-22

Código do produtoLYA

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Epi-Stop Nasal Gel/epistaxis pack is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Ent, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K230142. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Epi-Stop Nasal Gel/epistaxis pack?

Epi-Stop Nasal Gel/epistaxis pack is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Biomed Ent, Inc.. The 510(k) number is K230142.

When did Epi-Stop Nasal Gel/epistaxis pack receive FDA 510(k) clearance?

Epi-Stop Nasal Gel/epistaxis pack received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230142.

Who is the listed applicant for Epi-Stop Nasal Gel/epistaxis pack?

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

What is the FDA product code for Epi-Stop Nasal Gel/epistaxis pack?

The FDA product code for Epi-Stop Nasal Gel/epistaxis pack is LYA.

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