K914106

Substantially Equivalent

PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P

Applicant: Pentax Precision Instrument Corp.
Product code: FGB
Advisory panel: Gastroenterology, Urology
Date received: 1991-09-13
Decision date: 1992-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

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.