LEKSELL NEURO GENERATOR AND ACCESSORIES— 510(k) K941823

Name: FDA 510(k) clearance K941823
Creator: U.S. Food and Drug Administration
Published: 1996-03-22

Substantially Equivalent

Elekta Instruments, Inc.

FDA 510(k) clearance K941823 for LEKSELL NEURO GENERATOR AND ACCESSORIES, Substantially Equivalent on 1996-03-22. Applicant: Elekta Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Elekta Instruments, Inc.
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 1994-04-13
Decision date: 1996-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.