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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 / March 2026 / K252648

510(k) cleared

Niti-S SPAXUS Stent

Taewoong Medical Co., Ltd. · Mar 13, 2026 · K252648

FDA cleared the Niti-S SPAXUS Stent from Taewoong Medical Co., Ltd. on Mar 13, 2026 under K252648, a traditional 510(k). The device falls under product code PCU, Pancreatic Stent, Covered, Metallic, Removable, regulated at 21 CFR 876.5015 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 21, 2025. The decision came 204 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), K251123 (Niti-S Biliary Stent; Niti-S Biliary Slim M Stent), K243619 (Niti-S Esophageal Stent; Esophageal TTS Stent).

Questions & Answers

What did FDA clear under K252648?

K252648 is the FDA 510(k) for Niti-S SPAXUS Stent, submitted by Taewoong Medical Co., Ltd.. FDA's decision date was Mar 13, 2026, under product code PCU (Pancreatic Stent, Covered, Metallic, Removable).

Who makes the Niti-S SPAXUS Stent?

Taewoong Medical Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K252648.

How long did the K252648 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Mar 13, 2026, 204 days later.

← All decisions in March 2026

Sources