OLYMPUS OES OTV-S5C VIDEO SYSTEM— 510(k) K971416

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K971416 for OLYMPUS OES OTV-S5C VIDEO SYSTEM, Substantially Equivalent on 1997-07-16. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-16
Decision date: 1997-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.