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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 / October 2025 / K252903

510(k) cleared

Verruca-Freeze H Plus

Cryosurgery, Inc. · Oct 10, 2025 · K252903

FDA cleared the Verruca-Freeze H Plus from Cryosurgery, Inc. on Oct 10, 2025 under K252903, a special 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 11, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Cryosurgery, Inc. has one other decision in the tracker over the last 12 months: K253000 (CryoFreeze Wart and Skin Tag Remover).

Questions & Answers

What did FDA clear under K252903?

K252903 is the FDA 510(k) for Verruca-Freeze H Plus, submitted by Cryosurgery, Inc.. FDA's decision date was Oct 10, 2025, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Verruca-Freeze H Plus?

Cryosurgery, Inc., based in Nashville, TN, is the applicant of record for K252903.

How long did the K252903 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Oct 10, 2025, 29 days later.

← All decisions in October 2025

Sources