Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device— 510(k) K212301

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K212301 for Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device, Substantially Equivalent on 2021-11-15. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code LFL
Advisory panel: Unknown
Date received: 2021-07-23
Decision date: 2021-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.