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THE TAPE

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 / K261105

510(k) cleared

Powered Aventus Thrombectomy System

Inquis Medical · Jul 27, 2026 · K261105 · In the directory

FDA cleared the Powered Aventus Thrombectomy System from Inquis Medical on Jul 27, 2026 under K261105, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 3, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Inquis Medical has 3 other decisions in the tracker over the last 12 months: K262030 (Aventus Thrombectomy System), K260091 (Aventus Introducer Sheath), K253925 (Aventus Thrombectomy System).

Questions & Answers

What did FDA clear under K261105?

K261105 is the FDA 510(k) for Powered Aventus Thrombectomy System, submitted by Inquis Medical. FDA's decision date was Jul 27, 2026, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the Powered Aventus Thrombectomy System?

Inquis Medical, based in Menlo Park, CA, is the applicant of record for K261105. The company is listed in the MedDevice Startups directory.

How long did the K261105 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Jul 27, 2026, 115 days later.

← All decisions in July 2026

Sources

In the startup directory

Inquis Medical

Cardiovascular · Menlo Park, CA