GOLDEN SPYDER, MODEL GS-300— 510(k) K041341

Name: FDA 510(k) clearance K041341
Creator: U.S. Food and Drug Administration
Published: 2004-06-03

Substantially Equivalent

Golden Technologies, Inc.

FDA 510(k) clearance K041341 for GOLDEN SPYDER, MODEL GS-300, Substantially Equivalent on 2004-06-03. Applicant: Golden Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Golden Technologies, Inc.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2004-05-20
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Old Forge, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.