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 a medical device manufactured by Visby Medical, Inc.. It received FDA 510(k) clearance on 2025-10-01 under approval 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. It is manufactured by Visby Medical, Inc.. The 510(k) number is K251501.
When was Visby Medical Men's Sexual Health Test approved by the FDA?
Visby Medical Men's Sexual Health Test received FDA 510(k) clearance on 2025-10-01, under approval number K251501.
What company makes Visby Medical Men's Sexual Health Test?
Visby Medical Men's Sexual Health Test is manufactured by Visby Medical, Inc..
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.
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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.