FDA 510(k)

Ultramatrix EUS Balloon

Número K: K180731 · 2018-04-19

RequerenteUnited States Endoscopy Group, Inc. (Us Endoscopy)

Data da decisão2018-04-19

Código do produtoODG

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultramatrix EUS Balloon is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc. (Us Endoscopy). It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180731. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ultramatrix EUS Balloon?

Ultramatrix EUS Balloon is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is United States Endoscopy Group, Inc. (Us Endoscopy). The 510(k) number is K180731.

When did Ultramatrix EUS Balloon receive FDA 510(k) clearance?

Ultramatrix EUS Balloon received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180731.

Who is the listed applicant for Ultramatrix EUS Balloon?

The FDA 510(k) record lists United States Endoscopy Group, Inc. (Us Endoscopy) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultramatrix EUS Balloon?

The FDA product code for Ultramatrix EUS Balloon is ODG.

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