OLYMPUS VIDEO URETEROSCOPE, NTSC— 510(k) K033651

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K033651 for OLYMPUS VIDEO URETEROSCOPE, NTSC, Substantially Equivalent on 2004-01-30. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2003-11-20
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.