510(k) K172580— ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Substantially Equivalent

Ethicon Endo-Surgery, LLC

Clearance details

Applicant: Ethicon Endo-Surgery, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2017-08-28
Decision date: 2017-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guaynabo, PR, US

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.