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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 / February 2026 / K251860

510(k) cleared

Copioumed AAMI 3 Surgical Gown

Copioumed International, Inc. · Feb 26, 2026 · K251860

FDA cleared the Copioumed AAMI 3 Surgical Gown from Copioumed International, Inc. on Feb 26, 2026 under K251860, a traditional 510(k). The device falls under product code FYA, Gown, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 17, 2025. The decision came 254 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K251860?

K251860 is the FDA 510(k) for Copioumed AAMI 3 Surgical Gown, submitted by Copioumed International, Inc.. FDA's decision date was Feb 26, 2026, under product code FYA (Gown, Surgical).

Who makes the Copioumed AAMI 3 Surgical Gown?

Copioumed International, Inc., based in Taipei City, is the applicant of record for K251860.

How long did the K251860 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Feb 26, 2026, 254 days later.

← All decisions in February 2026