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FDA 510(k)

Planmed XFI

K-Number: K250318 · 2025-09-26

ApplicantPlanmed OY
Decision Date2025-09-26
Product CodeSFV
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmed XFI is a medical device manufactured by Planmed OY. It received FDA 510(k) clearance on 2025-09-26 under approval number K250318. The device is classified under product code SFV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Planmed XFI?

Planmed XFI is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Planmed OY. The 510(k) number is K250318.

When was Planmed XFI approved by the FDA?

Planmed XFI received FDA 510(k) clearance on 2025-09-26, under approval number K250318.

What company makes Planmed XFI?

Planmed XFI is manufactured by Planmed OY.

What is the FDA product code for Planmed XFI?

The FDA product code for Planmed XFI is SFV.

Other Devices by Planmed OY

K163328Planmed Clarity K180918Planmed Verity K192317Planmed Clarity 2D and Clarity S K211720Planmed Clarity 2D, Planmed Clarify S K213278Planmed Verity

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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