510(k) K012929— FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735

Substantially Equivalent

Circon Video

Clearance details

Applicant: Circon Video
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-31
Decision date: 2001-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.