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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 / September 2025 / K242287

510(k) cleared

SFIT Abutment

Cowellmedi Co., Ltd. · Sep 16, 2025 · K242287

FDA cleared the SFIT Abutment from Cowellmedi Co., Ltd. on Sep 16, 2025 under K242287, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 2, 2024. The decision came 410 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 Cowellmedi Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242287?

K242287 is the FDA 510(k) for SFIT Abutment, submitted by Cowellmedi Co., Ltd.. FDA's decision date was Sep 16, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the SFIT Abutment?

Cowellmedi Co., Ltd., based in Busan, is the applicant of record for K242287.

How long did the K242287 review take?

FDA received the submission on Aug 2, 2024 and issued its decision on Sep 16, 2025, 410 days later.

← All decisions in September 2025