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FDA 510(k)

ART-Plan+ (v3.1.0)

K-Number: K253091 · 2025-12-23

ApplicantTherapanacea Sas
Decision Date2025-12-23
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ART-Plan+ (v3.1.0) is a medical device manufactured by Therapanacea Sas. It received FDA 510(k) clearance on 2025-12-23 under approval number K253091. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART-Plan+ (v3.1.0)?

ART-Plan+ (v3.1.0) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Therapanacea Sas. The 510(k) number is K253091.

When was ART-Plan+ (v3.1.0) approved by the FDA?

ART-Plan+ (v3.1.0) received FDA 510(k) clearance on 2025-12-23, under approval number K253091.

What company makes ART-Plan+ (v3.1.0)?

ART-Plan+ (v3.1.0) is manufactured by Therapanacea Sas.

What is the FDA product code for ART-Plan+ (v3.1.0)?

The FDA product code for ART-Plan+ (v3.1.0) is MUJ.

Other Devices by Therapanacea Sas

K230023ART-Plan K234068ART-Plan (v.2.2.0) K242822ART-Plan+ (v.3.0.0)

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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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