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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 / April 2026 / K253243

510(k) cleared

Cardinal Health Poly Reinforced Surgical Gown

Cardinal Health 200, LLC · Apr 28, 2026 · K253243

FDA cleared the Cardinal Health Poly Reinforced Surgical Gown from Cardinal Health 200, LLC on Apr 28, 2026 under K253243, a abbreviated 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 Sep 29, 2025. The decision came 211 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 Cardinal Health 200, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253243?

K253243 is the FDA 510(k) for Cardinal Health Poly Reinforced Surgical Gown, submitted by Cardinal Health 200, LLC. FDA's decision date was Apr 28, 2026, under product code FYA (Gown, Surgical).

Who makes the Cardinal Health Poly Reinforced Surgical Gown?

Cardinal Health 200, LLC, based in Waukegan, IL, is the applicant of record for K253243.

How long did the K253243 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Apr 28, 2026, 211 days later.

← All decisions in April 2026