LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated— 510(k) K181085

Substantially Equivalent

Covidien

FDA 510(k) clearance K181085 for LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated, Substantially Equivalent on 2018-06-21. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2018-04-25
Decision date: 2018-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.