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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 / K252985

510(k) cleared

Laport

Sejong Medical Co., Ltd. · May 19, 2026 · K252985

FDA cleared the Laport from Sejong Medical Co., Ltd. on May 19, 2026 under K252985, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 18, 2025. The decision came 243 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sejong Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253165 (LAP-iX2N).

Questions & Answers

What did FDA clear under K252985?

K252985 is the FDA 510(k) for Laport, submitted by Sejong Medical Co., Ltd.. FDA's decision date was May 19, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Laport?

Sejong Medical Co., Ltd., based in Paju-Si, is the applicant of record for K252985.

How long did the K252985 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on May 19, 2026, 243 days later.

← All decisions in May 2026

Sources