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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 / September 2025 / K251734

510(k) cleared

ProVee Video Processing Unit (PV-003)

Proverum Limited · Sep 24, 2025 · K251734 · In the directory

FDA cleared the ProVee Video Processing Unit (PV-003) from Proverum Limited on Sep 24, 2025 under K251734, a traditional 510(k). The device falls under product code FET, Endoscopic Video Imaging System/Component, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 6, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Proverum Limited has one other decision in the tracker over the last 12 months: P250011 (ProVee System for BPH).

Questions & Answers

What did FDA clear under K251734?

K251734 is the FDA 510(k) for ProVee Video Processing Unit (PV-003), submitted by Proverum Limited. FDA's decision date was Sep 24, 2025, under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Who makes the ProVee Video Processing Unit (PV-003)?

Proverum Limited, based in Dublin 1, is the applicant of record for K251734. The company is listed in the MedDevice Startups directory.

How long did the K251734 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Sep 24, 2025, 110 days later.

← All decisions in September 2025

Sources

In the startup directory

ProVerum

GI & Urology · Dublin, Ireland