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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 / December 2025 / P250011

PMA approved

ProVee System for BPH

Proverum, Ltd. · Dec 9, 2025 · P250011 · In the directory

FDA approved the ProVee System for BPH from Proverum, Ltd. on Dec 9, 2025 under P250011, an original premarket approval. The device falls under product code MER, Stent, Urethral, Prostatic, Permanent Or Semi-Permanent as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 2, 2025. The decision came 251 days later.

Proverum, Ltd. has one other decision in the tracker over the last 12 months: K251734 (ProVee Video Processing Unit (PV-003)).

Questions & Answers

What did FDA approve under P250011?

P250011 is the FDA PMA for ProVee System for BPH, submitted by Proverum, Ltd.. FDA's decision date was Dec 9, 2025, under product code MER (Stent, Urethral, Prostatic, Permanent Or Semi-Permanent).

Who makes the ProVee System for BPH?

Proverum, Ltd., based in Dublin, is the applicant of record for P250011. The company is listed in the MedDevice Startups directory.

How long did the P250011 review take?

FDA received the submission on Apr 2, 2025 and issued its decision on Dec 9, 2025, 251 days later.

← All decisions in December 2025

Sources

In the startup directory

ProVerum

GI & Urology · Dublin, Ireland