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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 / April 2026 / K252198

510(k) cleared

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Medical Brands Laboratories B.V. · Apr 2, 2026 · K252198

FDA cleared the Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) from Medical Brands Laboratories B.V. on Apr 2, 2026 under K252198, a traditional 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 Jul 14, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medical Brands Laboratories B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252198?

K252198 is the FDA 510(k) for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover), submitted by Medical Brands Laboratories B.V.. FDA's decision date was Apr 2, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

Medical Brands Laboratories B.V., based in Diemen, is the applicant of record for K252198.

How long did the K252198 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Apr 2, 2026, 262 days later.

← All decisions in April 2026