DeviceClearance

K201066

Substantially Equivalent

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

Applicant
Ethicon Endo-Surgery, LLC
Product code
GEI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guaynabo, PR, 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, through . 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.