GUIDE WIRE— 510(k) K874164

Substantially Equivalent

Endovations

FDA 510(k) clearance K874164 for GUIDE WIRE, Substantially Equivalent on 1987-12-07. Applicant: Endovations.

Clearance details

Applicant: Endovations
Product code: Code EZB
Advisory panel: Gastroenterology, Urology
Date received: 1987-10-13
Decision date: 1987-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZB

product code EZB

Death: 4
Injury: 141
Malfunction: 588
Total: 733

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.