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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 / May 2026 / K252917

510(k) cleared

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Genesee Biomedical, Inc. · May 22, 2026 · K252917

FDA cleared the ATLAAS (Atraumatic Left Atrial Appendage System) (AD) from Genesee Biomedical, Inc. on May 22, 2026 under K252917, a traditional 510(k). The device falls under product code PZX, Left Atrial Appendage Clip, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 12, 2025. The decision came 252 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 Genesee Biomedical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252917?

K252917 is the FDA 510(k) for ATLAAS (Atraumatic Left Atrial Appendage System) (AD), submitted by Genesee Biomedical, Inc.. FDA's decision date was May 22, 2026, under product code PZX (Left Atrial Appendage Clip, Implantable).

Who makes the ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

Genesee Biomedical, Inc., based in Denver, CO, is the applicant of record for K252917.

How long did the K252917 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on May 22, 2026, 252 days later.

← All decisions in May 2026