MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002— 510(k) K071140

Name: FDA 510(k) clearance K071140
Creator: U.S. Food and Drug Administration
Published: 2007-06-07

Substantially Equivalent

Top Spins, Inc.

FDA 510(k) clearance K071140 for MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002, Substantially Equivalent on 2007-06-07. Applicant: Top Spins, Inc.. Device class: 1.

Clearance details

Applicant: Top Spins, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 2007-04-24
Decision date: 2007-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.