CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor— 510(k) K172666

Substantially Equivalent

Sutureease, Inc.

FDA 510(k) clearance K172666 for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor, Substantially Equivalent on 2017-12-01. Applicant: Sutureease, Inc..

Clearance details

Applicant: Sutureease, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2017-09-05
Decision date: 2017-12-01
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, 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.