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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 / March 2026 / K260532

510(k) cleared

Derma-Gide

Geistlich Pharma AG · Mar 19, 2026 · K260532

FDA cleared the Derma-Gide from Geistlich Pharma AG on Mar 19, 2026 under K260532, a special 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 Feb 17, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Geistlich Pharma AG has 3 other decisions in the tracker over the last 12 months: K260364 (Device 300419 Strip), K251323 (Device 104 Particulate), K252253 (Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®).

Questions & Answers

What did FDA clear under K260532?

K260532 is the FDA 510(k) for Derma-Gide, submitted by Geistlich Pharma AG. FDA's decision date was Mar 19, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Derma-Gide?

Geistlich Pharma AG, based in Wolhusen, is the applicant of record for K260532.

How long did the K260532 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Mar 19, 2026, 30 days later.

← All decisions in March 2026

Sources