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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 / November 2025 / K252253

510(k) cleared

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®

Geistlich Pharma AG · Nov 25, 2025 · K252253

FDA cleared the Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® from Geistlich Pharma AG on Nov 25, 2025 under K252253, a traditional 510(k). The device falls under product code NPL, Barrier, Animal Source, Intraoral, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 21, 2025. The decision came 127 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), K251323 (Device 104 Particulate).

Questions & Answers

What did FDA clear under K252253?

K252253 is the FDA 510(k) for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®, submitted by Geistlich Pharma AG. FDA's decision date was Nov 25, 2025, under product code NPL (Barrier, Animal Source, Intraoral).

Who makes the Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

Geistlich Pharma AG, based in Wolhusen, is the applicant of record for K252253.

How long did the K252253 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Nov 25, 2025, 127 days later.

← All decisions in November 2025

Sources