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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 / January 2026 / K251323

510(k) cleared

Device 104 Particulate

Geistlich Pharma AG · Jan 22, 2026 · K251323

FDA cleared the Device 104 Particulate from Geistlich Pharma AG on Jan 22, 2026 under K251323, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 29, 2025. The decision came 268 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: K260364 (Device 300419 Strip), K260532 (Derma-Gide), K252253 (Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®).

Questions & Answers

What did FDA clear under K251323?

K251323 is the FDA 510(k) for Device 104 Particulate, submitted by Geistlich Pharma AG. FDA's decision date was Jan 22, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Device 104 Particulate?

Geistlich Pharma AG, based in Wolhusen, is the applicant of record for K251323.

How long did the K251323 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Jan 22, 2026, 268 days later.

← All decisions in January 2026

Sources