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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K253905

510(k) cleared

PrimeSight UltraView System

Cogentix Medical, Inc. · Apr 7, 2026 · K253905

FDA cleared the PrimeSight UltraView System from Cogentix Medical, Inc. on Apr 7, 2026 under K253905, a traditional 510(k). The device falls under product code FAJ, Cystoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 5, 2025. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Cogentix Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253905?

K253905 is the FDA 510(k) for PrimeSight UltraView System, submitted by Cogentix Medical, Inc.. FDA's decision date was Apr 7, 2026, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the PrimeSight UltraView System?

Cogentix Medical, Inc., based in Orangeburg, NY, is the applicant of record for K253905.

How long did the K253905 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Apr 7, 2026, 123 days later.

← All decisions in April 2026