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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 / K260962

510(k) cleared

Sphincterotome

Taewoong Medical Co., Ltd. · May 21, 2026 · K260962

FDA cleared the Sphincterotome from Taewoong Medical Co., Ltd. on May 21, 2026 under K260962, a traditional 510(k). The device falls under product code KNS, Unit, Electrosurgical, Endoscopic (With Or Without Accessories), regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 23, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Taewoong Medical Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K252648 (Niti-S SPAXUS Stent), 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 K260962?

K260962 is the FDA 510(k) for Sphincterotome, submitted by Taewoong Medical Co., Ltd.. FDA's decision date was May 21, 2026, under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)).

Who makes the Sphincterotome?

Taewoong Medical Co., Ltd., based in Gimpo-Si, is the applicant of record for K260962.

How long did the K260962 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on May 21, 2026, 59 days later.

← All decisions in May 2026

Sources