Cook 810 Set, Desilets-Hoffman Introducer Set— 510(k) K180028

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K180028 for Cook 810 Set, Desilets-Hoffman Introducer Set, Substantially Equivalent on 2018-05-02. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-03
Decision date: 2018-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.