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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 / K261246

510(k) cleared

SRGC-06

GC America, Inc. · Jun 18, 2026 · K261246

FDA cleared the SRGC-06 from GC America, Inc. on Jun 18, 2026 under K261246, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 16, 2026. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

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), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K261246?

K261246 is the FDA 510(k) for SRGC-06, submitted by GC America, Inc.. FDA's decision date was Jun 18, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the SRGC-06?

GC America, Inc., based in Alsip, IL, is the applicant of record for K261246.

How long did the K261246 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Jun 18, 2026, 63 days later.

← All decisions in June 2026