FDA 510(k)

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

Número K: K201244 · 2020-08-07

Data da decisão2020-08-07

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is the device name listed in this FDA 510(k) record. The listed applicant is Transmed7, LLC. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201244. 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 Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Transmed7, LLC. The 510(k) number is K201244.

When did Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices receive FDA 510(k) clearance?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201244.

Who is the listed applicant for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA 510(k) record lists Transmed7, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is KNW.

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Outros registros que listam Transmed7, LLC como candidato(a)

K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device

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