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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 / December 2025 / K253609

510(k) cleared

TRAUMAGEL® 2.0 Hemostatic Gel

Cresilon, Inc. · Dec 12, 2025 · K253609

FDA cleared the TRAUMAGEL® 2.0 Hemostatic Gel from Cresilon, Inc. on Dec 12, 2025 under K253609, a special 510(k). The device falls under product code QSY, Hemostatic Wound Dressing Without Thrombin Or Other Biologics as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 18, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cresilon, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253609?

K253609 is the FDA 510(k) for TRAUMAGEL® 2.0 Hemostatic Gel, submitted by Cresilon, Inc.. FDA's decision date was Dec 12, 2025, under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics).

Who makes the TRAUMAGEL® 2.0 Hemostatic Gel?

Cresilon, Inc., based in Brooklyn, NY, is the applicant of record for K253609.

How long did the K253609 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Dec 12, 2025, 24 days later.

← All decisions in December 2025