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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 / October 2025 / K243619

510(k) cleared

Niti-S Esophageal Stent; Esophageal TTS Stent

Taewoong Medical Co., Ltd. · Oct 30, 2025 · K243619

FDA cleared the Niti-S Esophageal Stent; Esophageal TTS Stent from Taewoong Medical Co., Ltd. on Oct 30, 2025 under K243619, a traditional 510(k). The device falls under product code ESW, Prosthesis, Esophageal, regulated at 21 CFR 878.3610 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 22, 2024. The decision came 342 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Taewoong Medical Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K260962 (Sphincterotome), K252648 (Niti-S SPAXUS Stent), K251123 (Niti-S Biliary Stent; Niti-S Biliary Slim M Stent).

Questions & Answers

What did FDA clear under K243619?

K243619 is the FDA 510(k) for Niti-S Esophageal Stent; Esophageal TTS Stent, submitted by Taewoong Medical Co., Ltd.. FDA's decision date was Oct 30, 2025, under product code ESW (Prosthesis, Esophageal).

Who makes the Niti-S Esophageal Stent; Esophageal TTS Stent?

Taewoong Medical Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K243619.

How long did the K243619 review take?

FDA received the submission on Nov 22, 2024 and issued its decision on Oct 30, 2025, 342 days later.

← All decisions in October 2025

Sources