FDA 510(k)

EndoSign® Cell collection device (ES-CYT-102)

Número K: K233142 · 2024-01-19

Data da decisão2024-01-19

Código do produtoEOX

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

EndoSign® Cell collection device (ES-CYT-102) is the device name listed in this FDA 510(k) record. The listed applicant is Cyted Limited. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K233142. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EndoSign® Cell collection device (ES-CYT-102)?

EndoSign® Cell collection device (ES-CYT-102) is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Cyted Limited. The 510(k) number is K233142.

When did EndoSign® Cell collection device (ES-CYT-102) receive FDA 510(k) clearance?

EndoSign® Cell collection device (ES-CYT-102) received FDA 510(k) clearance on 2024-01-19, under 510(k) number K233142.

Who is the listed applicant for EndoSign® Cell collection device (ES-CYT-102)?

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

What is the FDA product code for EndoSign® Cell collection device (ES-CYT-102)?

The FDA product code for EndoSign® Cell collection device (ES-CYT-102) is EOX.

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