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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 / June 2026 / K261068

510(k) cleared

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Serpex Medical · Jun 30, 2026 · K261068

FDA cleared the Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) from Serpex Medical on Jun 30, 2026 under K261068, 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 Apr 1, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Serpex Medical has one other decision in the tracker over the last 12 months: K252874 (Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01).

Questions & Answers

What did FDA clear under K261068?

K261068 is the FDA 510(k) for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000), submitted by Serpex Medical. FDA's decision date was Jun 30, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)?

Serpex Medical, based in Santa Clara, CA, is the applicant of record for K261068.

How long did the K261068 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jun 30, 2026, 90 days later.

← All decisions in June 2026

Sources