OLYMPUS DISPOSABLE BIOPSY VALVE— 510(k) K911412

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K911412 for OLYMPUS DISPOSABLE BIOPSY VALVE, Substantially Equivalent on 1991-06-28. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1991-04-01
Decision date: 1991-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.