Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELEOS™ Limb Salvage System with NanoCept® Technology

K-Number: K252920 · 2025-10-15

ApplicantOnkos Surgical, Inc.
Decision Date2025-10-15
Product CodeQZZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELEOS™ Limb Salvage System with NanoCept® Technology is a medical device manufactured by Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-15 under approval number K252920. The device is classified under product code QZZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEOS™ Limb Salvage System with NanoCept® Technology?

ELEOS™ Limb Salvage System with NanoCept® Technology is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Onkos Surgical, Inc.. The 510(k) number is K252920.

When was ELEOS™ Limb Salvage System with NanoCept® Technology approved by the FDA?

ELEOS™ Limb Salvage System with NanoCept® Technology received FDA 510(k) clearance on 2025-10-15, under approval number K252920.

What company makes ELEOS™ Limb Salvage System with NanoCept® Technology?

ELEOS™ Limb Salvage System with NanoCept® Technology is manufactured by Onkos Surgical, Inc..

What is the FDA product code for ELEOS™ Limb Salvage System with NanoCept® Technology?

The FDA product code for ELEOS™ Limb Salvage System with NanoCept® Technology is QZZ.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT06335082 A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF ENROLLING_BY_INVITATION NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Onkos Surgical, Inc.

K161520ELEOS Limb Salvage System K180130ELEOS™ Bipolar Acetabular System K223348My3D® Personalized Pelvic Reconstruction

Related Devices (Code: QZZ)

DEN210058ELEOSx™ Limb Salvage SystemOnkos Surgical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑