K971937

Substantially Equivalent

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Applicant: Terumo Medical Corp.
Product code: OCY
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-27
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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.