ERCP CANNULA— 510(k) K905714

Substantially Equivalent

Everest Medical Corp.

FDA 510(k) clearance K905714 for ERCP CANNULA, Substantially Equivalent on 1991-02-01. Applicant: Everest Medical Corp..

Clearance details

Applicant: Everest Medical Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-21
Decision date: 1991-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.