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FDA 510(k)

CoLumboX

K-Number: K250367 · 2025-05-28

ApplicantSmart Soft Healthcare AD
Decision Date2025-05-28
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoLumboX is a medical device manufactured by Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2025-05-28 under approval number K250367. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLumboX?

CoLumboX is a medical device that received FDA 510(k) clearance on 2025-05-28. It is manufactured by Smart Soft Healthcare AD. The 510(k) number is K250367.

When was CoLumboX approved by the FDA?

CoLumboX received FDA 510(k) clearance on 2025-05-28, under approval number K250367.

What company makes CoLumboX?

CoLumboX is manufactured by Smart Soft Healthcare AD.

What is the FDA product code for CoLumboX?

The FDA product code for CoLumboX is QIH.

Other Devices by Smart Soft Healthcare AD

K220497CoLumbo K254015CoLumbo C-Spine

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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.

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