SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3— 510(k) K021989

Substantially Equivalent

Integra Neurosciences

FDA 510(k) clearance K021989 for SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3, Substantially Equivalent on 2002-09-13. Applicant: Integra Neurosciences.

Clearance details

Applicant: Integra Neurosciences
Product code: Code LFL
Advisory panel: Unknown
Date received: 2002-06-18
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.