TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH— 510(k) K140521

Substantially Equivalent

ArthroCare Corporation

FDA 510(k) clearance K140521 for TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH, Substantially Equivalent on 2014-06-10. Applicant: ArthroCare Corporation.

Clearance details

Applicant: ArthroCare Corporation
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2014-03-04
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.