FDA 510(k)

NeoNavia Biopsy System

Número K: K220595 · 2022-09-08

Data da decisão2022-09-08

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeoNavia Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Neodynamics AB. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K220595. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeoNavia Biopsy System?

NeoNavia Biopsy System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Neodynamics AB. The 510(k) number is K220595.

When did NeoNavia Biopsy System receive FDA 510(k) clearance?

NeoNavia Biopsy System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K220595.

Who is the listed applicant for NeoNavia Biopsy System?

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

What is the FDA product code for NeoNavia Biopsy System?

The FDA product code for NeoNavia Biopsy System is KNW.

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