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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 / K253230

510(k) cleared

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

Erbe Elektromedizin GmbH · Apr 22, 2026 · K253230

FDA cleared the ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe from Erbe Elektromedizin GmbH on Apr 22, 2026 under K253230, 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 Sep 29, 2025. The decision came 205 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Erbe Elektromedizin GmbH has 2 other decisions in the tracker over the last 12 months: K261806 (ERBECRYO 2 Cryosurgical Unit and Accessories), K253915 (MOVIVA® Hybrid Ablation Probe).

Questions & Answers

What did FDA clear under K253230?

K253230 is the FDA 510(k) for ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe, submitted by Erbe Elektromedizin GmbH. FDA's decision date was Apr 22, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe?

Erbe Elektromedizin GmbH, based in Tuebingen, is the applicant of record for K253230.

How long did the K253230 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Apr 22, 2026, 205 days later.

← All decisions in April 2026

Sources