MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)— 510(k) K090608

Name: FDA 510(k) clearance K090608
Creator: U.S. Food and Drug Administration
Published: 2010-06-14

Substantially Equivalent

Minta Medical Limited

FDA 510(k) clearance K090608 for MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B), Substantially Equivalent on 2010-06-14. Applicant: Minta Medical Limited. Device class: 2.

Clearance details

Applicant: Minta Medical Limited
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2009-03-06
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knowsley Merseyside, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.