NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE— 510(k) K121773

Name: FDA 510(k) clearance K121773
Creator: U.S. Food and Drug Administration
Published: 2012-09-21

Substantially Equivalent

Biomerics

FDA 510(k) clearance K121773 for NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE, Substantially Equivalent on 2012-09-21. Applicant: Biomerics. Device class: 2.

Clearance details

Applicant: Biomerics
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2012-06-18
Decision date: 2012-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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.