ULTRATHIN URETEROSCOPES— 510(k) K951855

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K951855 for ULTRATHIN URETEROSCOPES, Substantially Equivalent on 1995-08-16. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-21
Decision date: 1995-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, 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.