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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 / K253262

510(k) cleared

EmeryGlide (EG18008901)

Nano4imaging GmbH · Mar 6, 2026 · K253262

FDA cleared the EmeryGlide (EG18008901) from Nano4imaging GmbH on Mar 6, 2026 under K253262, a special 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 29, 2025. The decision came 158 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 Nano4imaging GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253262?

K253262 is the FDA 510(k) for EmeryGlide (EG18008901), submitted by Nano4imaging GmbH. FDA's decision date was Mar 6, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the EmeryGlide (EG18008901)?

Nano4imaging GmbH, based in Duesseldorf, is the applicant of record for K253262.

How long did the K253262 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Mar 6, 2026, 158 days later.

← All decisions in March 2026