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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 / K253066

510(k) cleared

ELEOS with NanoCept® Technology Limb Salvage System

Onkos Surgical, Inc. · Jun 8, 2026 · K253066

FDA cleared the ELEOS with NanoCept® Technology Limb Salvage System from Onkos Surgical, Inc. on Jun 8, 2026 under K253066, a traditional 510(k). The device falls under product code QZZ, Limb And Joint Salvage Device With Coating For Bacteria Reduction, regulated at 21 CFR 888.3900 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 22, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Onkos Surgical, Inc. has one other decision in the tracker over the last 12 months: K252920 (ELEOS Limb Salvage System with NanoCept® Technology).

Questions & Answers

What did FDA clear under K253066?

K253066 is the FDA 510(k) for ELEOS with NanoCept® Technology Limb Salvage System, submitted by Onkos Surgical, Inc.. FDA's decision date was Jun 8, 2026, under product code QZZ (Limb And Joint Salvage Device With Coating For Bacteria Reduction).

Who makes the ELEOS with NanoCept® Technology Limb Salvage System?

Onkos Surgical, Inc., based in Parsippany, NJ, is the applicant of record for K253066.

How long did the K253066 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 8, 2026, 259 days later.

← All decisions in June 2026

Sources