OLYMPUS GUIDE WIRE— 510(k) K933110

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K933110 for OLYMPUS GUIDE WIRE, Substantially Equivalent on 1993-11-04. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-25
Decision date: 1993-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, 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.