Visby Medical Men's Sexual Health Test— 510(k) K251501

Name: FDA 510(k) clearance K251501
Creator: U.S. Food and Drug Administration
Published: 2025-10-01

Substantially Equivalent

Visby Medical, Inc.

FDA 510(k) clearance K251501 for Visby Medical Men's Sexual Health Test, Substantially Equivalent on 2025-10-01. Applicant: Visby Medical, Inc.. Device class: 2.

Clearance details

Applicant: Visby Medical, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2025-05-15
Decision date: 2025-10-01
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.