FDA 510(k)

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

Número K: K190829 · 2019-12-19

RequerenteWilson-Cook Medical Inc./Cook Endoscopy

Data da decisão2019-12-19

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190829. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K190829.

When did Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) receive FDA 510(k) clearance?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190829.

Who is the listed applicant for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is FBK.

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Dispositivos Relacionados (Código: FBK)

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Fonte oficial

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