SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR— 510(k) K010309

Substantially Equivalent

Mutoh America Co., Ltd.

FDA 510(k) clearance K010309 for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR, Substantially Equivalent on 2001-04-18. Applicant: Mutoh America Co., Ltd..

Clearance details

Applicant: Mutoh America Co., Ltd.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2001-02-01
Decision date: 2001-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, 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.