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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 / K261191

510(k) cleared

Alians Elbow S

Newclip Technics · Jul 8, 2026 · K261191

FDA cleared the Alians Elbow S from Newclip Technics on Jul 8, 2026 under K261191, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 13, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Newclip Technics has 4 other decisions in the tracker over the last 12 months: K261511 (Xpert Ankle), K261038 (Xpert PFP), K253906 (Xpert Hand), K250767 (Newclip Patient-matched instrumentation non sterile PSI).

Questions & Answers

What did FDA clear under K261191?

K261191 is the FDA 510(k) for Alians Elbow S, submitted by Newclip Technics. FDA's decision date was Jul 8, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Alians Elbow S?

Newclip Technics, based in Haute-Goulaine, is the applicant of record for K261191.

How long did the K261191 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jul 8, 2026, 86 days later.

← All decisions in July 2026

Sources