ENDOSCOPE AND ACCOSSORIES— 510(k) K926004

Substantially Equivalent

Endomedix

FDA 510(k) clearance K926004 for ENDOSCOPE AND ACCOSSORIES, Substantially Equivalent on 1993-02-10. Applicant: Endomedix.

Clearance details

Applicant: Endomedix
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1992-11-27
Decision date: 1993-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.