WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K253915

510(k) cleared

MOVIVA® Hybrid Ablation Probe

Erbe Elektromedizin GmbH · Dec 18, 2025 · K253915

FDA cleared the MOVIVA® Hybrid Ablation Probe from Erbe Elektromedizin GmbH on Dec 18, 2025 under K253915, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 8, 2025. The decision came 10 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: K261806 (ERBECRYO 2 Cryosurgical Unit and Accessories), K253230 (ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe).

Questions & Answers

What did FDA clear under K253915?

K253915 is the FDA 510(k) for MOVIVA® Hybrid Ablation Probe, submitted by Erbe Elektromedizin GmbH. FDA's decision date was Dec 18, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the MOVIVA® Hybrid Ablation Probe?

Erbe Elektromedizin GmbH, based in Tuebingen, is the applicant of record for K253915.

How long did the K253915 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Dec 18, 2025, 10 days later.

← All decisions in December 2025

Sources