MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON— 510(k) K013737

Substantially Equivalent

Telemed Systems, Inc.

FDA 510(k) clearance K013737 for MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON, Substantially Equivalent on 2002-03-01. Applicant: Telemed Systems, Inc..

Clearance details

Applicant: Telemed Systems, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2001-11-13
Decision date: 2002-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, MA, US

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.