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FDA 510(k)

FP3D

K-Number: K250489 · 2025-05-20

ApplicantKeystone Industries
Decision Date2025-05-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FP3D is a medical device manufactured by Keystone Industries. It received FDA 510(k) clearance on 2025-05-20 under approval number K250489. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FP3D?

FP3D is a medical device that received FDA 510(k) clearance on 2025-05-20. It is manufactured by Keystone Industries. The 510(k) number is K250489.

When was FP3D approved by the FDA?

FP3D received FDA 510(k) clearance on 2025-05-20, under approval number K250489.

What company makes FP3D?

FP3D is manufactured by Keystone Industries.

What is the FDA product code for FP3D?

The FDA product code for FP3D is EBI.

Other Devices by Keystone Industries

K183598KeyPrint KeySplint Soft K241089KeyPrint KeyDenture Base

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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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