PrimeSight UltraView System— 510(k) K253905

Substantially Equivalent

Cogentix Medical, Inc.

FDA 510(k) clearance K253905 for PrimeSight UltraView System, Substantially Equivalent on 2026-04-07. Applicant: Cogentix Medical, Inc..

Clearance details

Applicant: Cogentix Medical, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-05
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, 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.