Peel-Away Introducer— 510(k) K182403

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K182403 for Peel-Away Introducer, Substantially Equivalent on 2019-05-29. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-04
Decision date: 2019-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.