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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 / July 2026 / K261573

510(k) cleared

ENDOSCOPE HOLDER (182214)

Aktormed GmbH · Jul 20, 2026 · K261573

FDA cleared the ENDOSCOPE HOLDER (182214) from Aktormed GmbH on Jul 20, 2026 under K261573, a traditional 510(k). The device falls under product code QZB, Software Controlled Endoscope And Instrument Holder, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 12, 2026. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Aktormed GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261573?

K261573 is the FDA 510(k) for ENDOSCOPE HOLDER (182214), submitted by Aktormed GmbH. FDA's decision date was Jul 20, 2026, under product code QZB (Software Controlled Endoscope And Instrument Holder).

Who makes the ENDOSCOPE HOLDER (182214)?

Aktormed GmbH, based in Neutraubling, is the applicant of record for K261573.

How long did the K261573 review take?

FDA received the submission on May 12, 2026 and issued its decision on Jul 20, 2026, 69 days later.

← All decisions in July 2026