WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K251123

510(k) cleared

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

Taewoong Medical Co., Ltd. · Dec 29, 2025 · K251123

FDA cleared the Niti-S Biliary Stent; Niti-S Biliary Slim M Stent from Taewoong Medical Co., Ltd. on Dec 29, 2025 under K251123, a traditional 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 11, 2025. The decision came 262 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), K243619 (Niti-S Esophageal Stent; Esophageal TTS Stent).

Questions & Answers

What did FDA clear under K251123?

K251123 is the FDA 510(k) for Niti-S Biliary Stent; Niti-S Biliary Slim M Stent, submitted by Taewoong Medical Co., Ltd.. FDA's decision date was Dec 29, 2025, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

Taewoong Medical Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K251123.

How long did the K251123 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Dec 29, 2025, 262 days later.

← All decisions in December 2025

Sources