510(k) K170323— Entuit Start Initial Placement Gastrostomy Set

Substantially Equivalent

Cook Incorporated

Clearance details

Applicant: Cook Incorporated
Product code: Code KGC
Advisory panel: Gastroenterology, Urology
Date received: 2017-02-01
Decision date: 2017-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.