DeviceClearance

K091417

Substantially Equivalent

SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A

Applicant
Terumo Corp.
Product code
OCY
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elkton, MD, 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, through . 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.