510(k) K040215— VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM

Substantially Equivalent

Vision-Sciences, Inc.

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2004-01-30
Decision date: 2004-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, 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.