CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION— 510(k) K933906

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K933906 for CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION, Substantially Equivalent on 1994-07-08. Applicant: Fujinon, Inc..

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-11
Decision date: 1994-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.