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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 / July 2026 / K261179

510(k) cleared

AlphaTriPart - Monopolar MIC Instruments

Gimmi GmbH · Jul 22, 2026 · K261179

FDA cleared the AlphaTriPart - Monopolar MIC Instruments from Gimmi GmbH on Jul 22, 2026 under K261179, 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 Apr 10, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gimmi GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261179?

K261179 is the FDA 510(k) for AlphaTriPart - Monopolar MIC Instruments, submitted by Gimmi GmbH. FDA's decision date was Jul 22, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the AlphaTriPart - Monopolar MIC Instruments?

Gimmi GmbH, based in Tuttlingen, is the applicant of record for K261179.

How long did the K261179 review take?

FDA received the submission on Apr 10, 2026 and issued its decision on Jul 22, 2026, 103 days later.

← All decisions in July 2026