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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 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.

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. 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.

Related Devices (Code: ODG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.

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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