Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI— 510(k) K984298

Substantially Equivalent

Z-Kat, Inc.

FDA 510(k) clearance K984298 for Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI, Substantially Equivalent on 1999-06-23. Applicant: Z-Kat, Inc..

Clearance details

Applicant: Z-Kat, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1998-12-02
Decision date: 1999-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.