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FDA 510(k)

Prostate Core

K-Number: K253794 · 2026-08-10

ApplicantLucida Medical, Ltd.
Decision Date2026-08-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Prostate Core is the device name listed in this FDA 510(k) record. The listed applicant is Lucida Medical, Ltd.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K253794. 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 Prostate Core?

Prostate Core is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Lucida Medical, Ltd.. The 510(k) number is K253794.

When did Prostate Core receive FDA 510(k) clearance?

Prostate Core received FDA 510(k) clearance on 2026-08-10, under 510(k) number K253794.

Who is the listed applicant for Prostate Core?

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

What is the FDA product code for Prostate Core?

The FDA product code for Prostate Core is QIH.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.K261349SwiftMRAirs Medical, Inc.

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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