FDA 510(k)

SchurSign Tissue Marker

Número K: K230836 · 2024-01-23

Data da decisão2024-01-23

Código do produtoNEU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SchurSign Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Surgmark GmbH. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K230836. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SchurSign Tissue Marker?

SchurSign Tissue Marker is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Surgmark GmbH. The 510(k) number is K230836.

When did SchurSign Tissue Marker receive FDA 510(k) clearance?

SchurSign Tissue Marker received FDA 510(k) clearance on 2024-01-23, under 510(k) number K230836.

Who is the listed applicant for SchurSign Tissue Marker?

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

What is the FDA product code for SchurSign Tissue Marker?

The FDA product code for SchurSign Tissue Marker is NEU.

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