GIP/MEDI-GLOBE POLYPECTOMY SNARES— 510(k) K943935

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K943935 for GIP/MEDI-GLOBE POLYPECTOMY SNARES, Substantially Equivalent on 1995-05-26. Applicant: Medi-Globe Corp..

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-12
Decision date: 1995-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.