PrimeSight UltraView System— 510(k) K253905
Substantially EquivalentCogentix Medical, Inc.
FDA 510(k) clearance K253905 for PrimeSight UltraView System, Substantially Equivalent on 2026-04-07. Applicant: Cogentix Medical, Inc.. Device class: 2.
Summary
Cogentix Medical's PrimeSight UltraView System is filed under product code FAJ (Cystoscope And Accessories, Flexible/Rigid). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Cogentix Medical filed from Orangeburg, New York. The decision came 123 calendar days after FDA received it (December 5, 2025 to April 7, 2026).
Clearance details
- Applicant
- Cogentix Medical, Inc.
- Product code
- Product code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
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- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
More clearances from Cogentix Medical, Inc.
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . 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.