ALVUE Balloon Dilation System— 510(k) K171939

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K171939 for ALVUE Balloon Dilation System, Substantially Equivalent on 2018-03-07. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-28
Decision date: 2018-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.