EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830— 510(k) K010714

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K010714 for EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830, Substantially Equivalent on 2003-01-21. Applicant: Medi-Globe Corp..

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2001-03-09
Decision date: 2003-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Achenmuhle, DE

Download summary PDF View on FDA.gov ↗

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.