BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000— 510(k) K880166

Substantially Equivalent

Clinical Technology Corp.

FDA 510(k) clearance K880166 for BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000, Substantially Equivalent on 1988-02-18. Applicant: Clinical Technology Corp..

Clearance details

Applicant: Clinical Technology Corp.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1988-01-14
Decision date: 1988-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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.