MRI FASTSYSTEM RETRACTOR SYSTEM— 510(k) K001339

Name: FDA 510(k) clearance K001339
Creator: U.S. Food and Drug Administration
Published: 2000-05-17

Substantially Equivalent

Omni-Tract Surgical, Div. Minn. Scientific, Inc.

FDA 510(k) clearance K001339 for MRI FASTSYSTEM RETRACTOR SYSTEM, Substantially Equivalent on 2000-05-17. Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Omni-Tract Surgical, Div. Minn. Scientific, Inc.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2000-04-27
Decision date: 2000-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.