DeviceClearance

K172666

Substantially Equivalent

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor

Applicant
Sutureease, Inc.
Product code
OCW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW
Death
6
Injury
443
Malfunction
1,023
Other
2
Total
1,474

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.