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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 / K253317

510(k) cleared

Cytrans Elashield

GC America, Inc. · Jul 6, 2026 · K253317

FDA cleared the Cytrans Elashield from GC America, Inc. on Jul 6, 2026 under K253317, a traditional 510(k). The device falls under product code LYC, Bone Grafting Material, Synthetic, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 279 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GC America, Inc. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253802 (KHEIRON® Spinal Fixation System, including patient specific K-ROD).

Questions & Answers

What did FDA clear under K253317?

K253317 is the FDA 510(k) for Cytrans Elashield, submitted by GC America, Inc.. FDA's decision date was Jul 6, 2026, under product code LYC (Bone Grafting Material, Synthetic).

Who makes the Cytrans Elashield?

GC America, Inc., based in Alsip, IL, is the applicant of record for K253317.

How long did the K253317 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jul 6, 2026, 279 days later.

← All decisions in July 2026