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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 / March 2026 / K253734

510(k) cleared

Taurus Clip

Taurus Endoscopy · Mar 12, 2026 · K253734

FDA cleared the Taurus Clip from Taurus Endoscopy on Mar 12, 2026 under K253734, a traditional 510(k). The device falls under product code PKL, Hemostatic Metal Clip For The Gi Tract, regulated at 21 CFR 876.4400 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 24, 2025. The decision came 108 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 Taurus Endoscopy in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253734?

K253734 is the FDA 510(k) for Taurus Clip, submitted by Taurus Endoscopy. FDA's decision date was Mar 12, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the Taurus Clip?

Taurus Endoscopy, based in Strasbourg, is the applicant of record for K253734.

How long did the K253734 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Mar 12, 2026, 108 days later.

← All decisions in March 2026