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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 / June 2026 / K260006

510(k) cleared

INOSS System

Inosys, Inc. · Jun 17, 2026 · K260006

FDA cleared the INOSS System from Inosys, Inc. on Jun 17, 2026 under K260006, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 2, 2026. The decision came 166 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 Inosys, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260006?

K260006 is the FDA 510(k) for INOSS System, submitted by Inosys, Inc.. FDA's decision date was Jun 17, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the INOSS System?

Inosys, Inc., based in New York, NY, is the applicant of record for K260006.

How long did the K260006 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Jun 17, 2026, 166 days later.

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