Oracle EUS Balloon +4 more— 510(k) K163492

Clearance details

Device name as filed

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

Applicant

United States Endoscopy Group, Inc.

Product code

Code FDF

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2016-12-13

Decision date

2017-01-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Mentor, OH, US

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Death

8

Injury

729

Malfunction

61,773

Total

62,510

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →