VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM— 510(k) K072180

Substantially Equivalent

Vision-Sciences, Inc.

FDA 510(k) clearance K072180 for VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM, Substantially Equivalent on 2007-12-18. Applicant: Vision-Sciences, Inc..

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2007-08-06
Decision date: 2007-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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.