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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 / K260565

510(k) cleared

SmartClip Delivery Catheter (ADR-1715)

Elucent Medical · May 14, 2026 · K260565

FDA cleared the SmartClip Delivery Catheter (ADR-1715) from Elucent Medical on May 14, 2026 under K260565, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 19, 2026. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Elucent Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260565?

K260565 is the FDA 510(k) for SmartClip Delivery Catheter (ADR-1715), submitted by Elucent Medical. FDA's decision date was May 14, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the SmartClip Delivery Catheter (ADR-1715)?

Elucent Medical, based in Eden Prairie, MN, is the applicant of record for K260565.

How long did the K260565 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on May 14, 2026, 84 days later.

← All decisions in May 2026