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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 / June 2026 / K260364

510(k) cleared

Device 300419 Strip

Geistlich Pharma AG · Jun 2, 2026 · K260364

FDA cleared the Device 300419 Strip from Geistlich Pharma AG on Jun 2, 2026 under K260364, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 4, 2026. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Geistlich Pharma AG has 3 other decisions in the tracker over the last 12 months: K260532 (Derma-Gide), K251323 (Device 104 Particulate), K252253 (Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®).

Questions & Answers

What did FDA clear under K260364?

K260364 is the FDA 510(k) for Device 300419 Strip, submitted by Geistlich Pharma AG. FDA's decision date was Jun 2, 2026, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the Device 300419 Strip?

Geistlich Pharma AG, based in Wolhusen, is the applicant of record for K260364.

How long did the K260364 review take?

FDA received the submission on Feb 4, 2026 and issued its decision on Jun 2, 2026, 118 days later.

← All decisions in June 2026

Sources