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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 / K253620

510(k) cleared

TroClose 1200

Gordian Surgical, Ltd. · Dec 16, 2025 · K253620

FDA cleared the TroClose 1200 from Gordian Surgical, Ltd. on Dec 16, 2025 under K253620, a special 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 18, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Gordian Surgical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253620?

K253620 is the FDA 510(k) for TroClose 1200, submitted by Gordian Surgical, Ltd.. FDA's decision date was Dec 16, 2025, under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Who makes the TroClose 1200?

Gordian Surgical, Ltd., based in Misgav, is the applicant of record for K253620.

How long did the K253620 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Dec 16, 2025, 28 days later.

← All decisions in December 2025