ETHEREA— 510(k) K112505

Substantially Equivalent

Regulatory Insight, Inc.

FDA 510(k) clearance K112505 for ETHEREA, Substantially Equivalent on 2012-04-06. Applicant: Regulatory Insight, Inc..

Clearance details

Applicant: Regulatory Insight, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2011-08-30
Decision date: 2012-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.