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FDA 510(k)

Ultramatrix EUS Balloon

K-Number: K180731 · 2018-04-19

ApplicantUnited States Endoscopy Group, Inc. (Us Endoscopy)
Decision Date2018-04-19
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Ultramatrix EUS Balloon?

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

When was Ultramatrix EUS Balloon approved by the FDA?

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

What company makes Ultramatrix EUS Balloon?

Ultramatrix EUS Balloon is manufactured by United States Endoscopy Group, Inc. (Us Endoscopy).

What is the FDA product code for Ultramatrix EUS Balloon?

The FDA product code for Ultramatrix EUS Balloon is ODG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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