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FDA 510(k)

ELEOS™ with NanoCept® Technology Limb Salvage System

K-Number: K253066 · 2026-06-08

Decision Date2026-06-08
Product CodeQZZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELEOS™ with NanoCept® Technology Limb Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K253066. 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™ with NanoCept® Technology Limb Salvage System?

ELEOS™ with NanoCept® Technology Limb Salvage System is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K253066.

When did ELEOS™ with NanoCept® Technology Limb Salvage System receive FDA 510(k) clearance?

ELEOS™ with NanoCept® Technology Limb Salvage System received FDA 510(k) clearance on 2026-06-08, under 510(k) number K253066.

Who is the listed applicant for ELEOS™ with NanoCept® Technology Limb Salvage System?

The FDA 510(k) record lists Onkos Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Onkos Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: QZZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.