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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 / K261806

510(k) cleared

ERBECRYO 2 Cryosurgical Unit and Accessories

Erbe Elektromedizin GmbH · Jun 9, 2026 · K261806

FDA cleared the ERBECRYO 2 Cryosurgical Unit and Accessories from Erbe Elektromedizin GmbH on Jun 9, 2026 under K261806, 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 Jun 1, 2026. The decision came 8 days later, inside the 90 FDA-day goal for a 510(k).

Erbe Elektromedizin GmbH has 2 other decisions in the tracker over the last 12 months: K253230 (ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe), K253915 (MOVIVA® Hybrid Ablation Probe).

Questions & Answers

What did FDA clear under K261806?

K261806 is the FDA 510(k) for ERBECRYO 2 Cryosurgical Unit and Accessories, submitted by Erbe Elektromedizin GmbH. FDA's decision date was Jun 9, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the ERBECRYO 2 Cryosurgical Unit and Accessories?

Erbe Elektromedizin GmbH, based in Tuebingen, is the applicant of record for K261806.

How long did the K261806 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Jun 9, 2026, 8 days later.

← All decisions in June 2026

Sources