Radifocus Glidewire Endoscopic Wire— 510(k) K151471

Substantially Equivalent

Terumo Medical Corporation

FDA 510(k) clearance K151471 for Radifocus Glidewire Endoscopic Wire, Substantially Equivalent on 2015-09-17. Applicant: Terumo Medical Corporation.

Clearance details

Applicant: Terumo Medical Corporation
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2015-06-01
Decision date: 2015-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.