K101797

Substantially Equivalent

SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T

Applicant: Covidien, Formerly Valleylab, A Division of Tyco
Product code: LFL
Advisory panel: Unknown
Date received: 2010-06-28
Decision date: 2011-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.