LEKSELL STEREOTACTIC SYSTEM— 510(k) K972324

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K972324 for LEKSELL STEREOTACTIC SYSTEM, Substantially Equivalent on 1998-03-02. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code HAW
Advisory panel: Neurology
Date received: 1997-06-23
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.