URETERO-RENOSCOPE— 510(k) K992527

Substantially Equivalent

Fiber Imaging Technologies, Inc.

FDA 510(k) clearance K992527 for URETERO-RENOSCOPE, Substantially Equivalent on 1999-10-13. Applicant: Fiber Imaging Technologies, Inc..

Clearance details

Applicant: Fiber Imaging Technologies, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-28
Decision date: 1999-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, 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.