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FDA 510(k)

Visby Medical Men's Sexual Health Test

K-Number: K251501 · 2025-10-01

ApplicantVisby Medical, Inc.
Decision Date2025-10-01
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Visby Medical Men's Sexual Health Test is the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical, Inc.. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K251501. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visby Medical Men's Sexual Health Test?

Visby Medical Men's Sexual Health Test is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Visby Medical, Inc.. The 510(k) number is K251501.

When did Visby Medical Men's Sexual Health Test receive FDA 510(k) clearance?

Visby Medical Men's Sexual Health Test received FDA 510(k) clearance on 2025-10-01, under 510(k) number K251501.

Who is the listed applicant for Visby Medical Men's Sexual Health Test?

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

What is the FDA product code for Visby Medical Men's Sexual Health Test?

The FDA product code for Visby Medical Men's Sexual Health Test is QEP.

Other records listing Visby Medical, Inc. as applicant

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.

K253971Visby Medical Flu and COVID-19 TestK242526Visby Medical Respiratory Health TestK220407Visby Medical Sexual Health TestK200748Visby Medical Sexual Health

Related Devices (Code: QEP)

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.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, 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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