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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 / P250007

PMA approved

Zenflow Spring® Implant and Delivery System

Zenflow, Inc. · Dec 11, 2025 · P250007 · In the directory

FDA approved the Zenflow Spring® Implant and Delivery System from Zenflow, Inc. on Dec 11, 2025 under P250007, 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 Mar 11, 2025. The decision came 275 days later.

Zenflow, Inc. has one other decision in the tracker over the last 12 months: K251140 (Zenflow Spring Scope).

Questions & Answers

What did FDA approve under P250007?

P250007 is the FDA PMA for Zenflow Spring® Implant and Delivery System, submitted by Zenflow, Inc.. FDA's decision date was Dec 11, 2025, under product code MER (Stent, Urethral, Prostatic, Permanent Or Semi-Permanent).

Who makes the Zenflow Spring® Implant and Delivery System?

Zenflow, Inc., based in South San Francisco, CA, is the applicant of record for P250007. The company is listed in the MedDevice Startups directory.

How long did the P250007 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Dec 11, 2025, 275 days later.

← All decisions in December 2025

Sources

In the startup directory

Zenflow

GI & Urology · San Francisco, CA