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THE TAPE

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 / November 2025 / K252845

510(k) cleared

Venus Nova (FP-2001)

Venus Concept, Inc. · Nov 6, 2025 · K252845

FDA cleared the Venus Nova (FP-2001) from Venus Concept, Inc. on Nov 6, 2025 under K252845, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 8, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252845?

K252845 is the FDA 510(k) for Venus Nova (FP-2001), submitted by Venus Concept, Inc.. FDA's decision date was Nov 6, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Venus Nova (FP-2001)?

Venus Concept, Inc., based in San Jose, CA, is the applicant of record for K252845.

How long did the K252845 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Nov 6, 2025, 59 days later.

← All decisions in November 2025