GO MEDICAL BALLOON INFUSION SYSTEM— 510(k) K000263

Name: FDA 510(k) clearance K000263
Creator: U.S. Food and Drug Administration
Published: 2000-05-09

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K000263 for GO MEDICAL BALLOON INFUSION SYSTEM, Substantially Equivalent on 2000-05-09. Applicant: Go Medical Industries Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2000-01-28
Decision date: 2000-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Subiaco, Perth, AU

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.