ELEOS Limb Salvage System
K-Number: K161520 · 2016-10-28
ApplicantOnkos Surgical, Inc.
Decision Date2016-10-28
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ELEOS Limb Salvage System is a medical device manufactured by Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2016-10-28 under approval number K161520. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELEOS Limb Salvage System?
ELEOS Limb Salvage System is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Onkos Surgical, Inc.. The 510(k) number is K161520.
When was ELEOS Limb Salvage System approved by the FDA?
ELEOS Limb Salvage System received FDA 510(k) clearance on 2016-10-28, under approval number K161520.
What company makes ELEOS Limb Salvage System?
ELEOS Limb Salvage System is manufactured by Onkos Surgical, Inc..
What is the FDA product code for ELEOS Limb Salvage System?
The FDA product code for ELEOS Limb Salvage System is KRO.
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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.