OLEA SPHERE— 510(k) K120196

Substantially Equivalent

Olea Medical

FDA 510(k) clearance K120196 for OLEA SPHERE, Substantially Equivalent on 2012-04-19. Applicant: Olea Medical.

Clearance details

Applicant: Olea Medical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-01-23
Decision date: 2012-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.