K253905
- 510(k) number
- K253905
- Device name
- PrimeSight UltraView System
- Applicant
- Cogentix Medical, Inc. NY · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-04-07
- Date received
- 2025-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253905.pdf
Official FDA record: K253905
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.