FDA 510(k)

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Número K: K252646 · 2025-10-24

Data da decisão2025-10-24

Código do produtoFCG

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K252646. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K252646.

When did Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) receive FDA 510(k) clearance?

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K252646.

Who is the listed applicant for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?

The FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is FCG.

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Outros registros que listam Olympus Medical Systems Corp. como candidato(a)

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Fonte oficial

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