FUJI CATHETER, MODEL CTH001— 510(k) K983867

Substantially Equivalent

Windy Hill Technology, Inc.

FDA 510(k) clearance K983867 for FUJI CATHETER, MODEL CTH001, Substantially Equivalent on 1999-06-09. Applicant: Windy Hill Technology, Inc..

Clearance details

Applicant: Windy Hill Technology, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1998-11-02
Decision date: 1999-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.