RIGID URETEROSCOPE— 510(k) K901214

Substantially Equivalent

Applied Urology, Inc.

FDA 510(k) clearance K901214 for RIGID URETEROSCOPE, Substantially Equivalent on 1990-06-01. Applicant: Applied Urology, Inc..

Clearance details

Applicant: Applied Urology, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-14
Decision date: 1990-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, 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.