MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)— 510(k) K970471

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K970471 for MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS), Substantially Equivalent on 1997-07-17. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1997-02-07
Decision date: 1997-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, 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.