PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A— 510(k) K821974

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K821974 for PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A, Substantially Equivalent on 1982-08-10. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1982-07-02
Decision date: 1982-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.