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FDA 510(k)

Potenza Prime

K-Number: K254185 · 2026-09-11

ApplicantJeisys Medical Incorporated
Decision Date2026-09-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Potenza Prime is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K254185. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Potenza Prime?

Potenza Prime is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K254185.

When did Potenza Prime receive FDA 510(k) clearance?

Potenza Prime received FDA 510(k) clearance on 2026-09-11, under 510(k) number K254185.

Who is the listed applicant for Potenza Prime?

The FDA 510(k) record lists Jeisys Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Potenza Prime?

The FDA product code for Potenza Prime is GEI.

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Related Devices (Code: GEI)

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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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