APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE— 510(k) K012951

Substantially Equivalent

Circon Video

FDA 510(k) clearance K012951 for APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE, Substantially Equivalent on 2001-11-09. Applicant: Circon Video.

Clearance details

Applicant: Circon Video
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-04
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, 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.