LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE— 510(k) K946033

Substantially Equivalent

Leibinger GmbH

FDA 510(k) clearance K946033 for LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE, Substantially Equivalent on 1995-09-01. Applicant: Leibinger GmbH.

Clearance details

Applicant: Leibinger GmbH
Product code: Code HAW
Advisory panel: Neurology
Date received: 1994-12-09
Decision date: 1995-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.