PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P— 510(k) K914008

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K914008 for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P, Substantially Equivalent on 1992-01-10. Applicant: Pentax Precision Instrument Corp..

Clearance details

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

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.