450CM GUIDE WIRE FOR G.I. USE— 510(k) K910722

Substantially Equivalent

Terumo Corp.

FDA 510(k) clearance K910722 for 450CM GUIDE WIRE FOR G.I. USE, Substantially Equivalent on 1991-03-21. Applicant: Terumo Corp..

Clearance details

Applicant: Terumo Corp.
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 1991-02-20
Decision date: 1991-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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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.