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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 / October 2025 / K252920

510(k) cleared

ELEOS Limb Salvage System with NanoCept® Technology

Onkos Surgical, Inc. · Oct 15, 2025 · K252920

FDA cleared the ELEOS Limb Salvage System with NanoCept® Technology from Onkos Surgical, Inc. on Oct 15, 2025 under K252920, a special 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 12, 2025. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

Onkos Surgical, Inc. has one other decision in the tracker over the last 12 months: K253066 (ELEOS with NanoCept® Technology Limb Salvage System).

Questions & Answers

What did FDA clear under K252920?

K252920 is the FDA 510(k) for ELEOS Limb Salvage System with NanoCept® Technology, submitted by Onkos Surgical, Inc.. FDA's decision date was Oct 15, 2025, under product code QZZ (Limb And Joint Salvage Device With Coating For Bacteria Reduction).

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

Onkos Surgical, Inc., based in Parsippany, NJ, is the applicant of record for K252920.

How long did the K252920 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Oct 15, 2025, 33 days later.

← All decisions in October 2025

Sources