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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 / October 2025 / K252367

510(k) cleared

InbellaMulti System

Inbella Medical, Inc. · Oct 15, 2025 · K252367

FDA cleared the InbellaMulti System from Inbella Medical, Inc. on Oct 15, 2025 under K252367, 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 Jul 30, 2025. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

Inbella Medical, Inc. has one other decision in the tracker over the last 12 months: K251435 (InbellaIgnite RF System).

Questions & Answers

What did FDA clear under K252367?

K252367 is the FDA 510(k) for InbellaMulti System, submitted by Inbella Medical, Inc.. FDA's decision date was Oct 15, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the InbellaMulti System?

Inbella Medical, Inc., based in Richmond Hill, is the applicant of record for K252367.

How long did the K252367 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Oct 15, 2025, 77 days later.

← All decisions in October 2025

Sources