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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 / December 2025 / K251562

510(k) cleared

OTSCneo System Set (100.03n-14n, 100.27n-31n)

Ovesco Endoscopy AG · Dec 18, 2025 · K251562

FDA cleared the OTSCneo System Set (100.03n-14n, 100.27n-31n) from Ovesco Endoscopy AG on Dec 18, 2025 under K251562, 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 May 22, 2025. The decision came 210 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 Ovesco Endoscopy AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251562?

K251562 is the FDA 510(k) for OTSCneo System Set (100.03n-14n, 100.27n-31n), submitted by Ovesco Endoscopy AG. FDA's decision date was Dec 18, 2025, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the OTSCneo System Set (100.03n-14n, 100.27n-31n)?

Ovesco Endoscopy AG, based in Tuebingen, is the applicant of record for K251562.

How long did the K251562 review take?

FDA received the submission on May 22, 2025 and issued its decision on Dec 18, 2025, 210 days later.

← All decisions in December 2025