510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240020Unknown

Visby Medical Women's Sexual Health Test

Visby Medical, Inc., San Jose CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240020 is the FDA 510(k) clearance record for Visby Medical Women's Sexual Health Test, a class II device, cleared for Visby Medical, Inc. on under FDA product code SEA (Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users). FDA's definition for product code SEA reads: "This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar...". FDA records list 6 510(k) clearances for Visby Medical, Inc., from to . As of , FDA records show no recalls naming DEN240020.

Clearance record

Decision date
Received
(319 days to decision)
Product code
SEA Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Regulation
21 CFR 866.3386
Device class
Class II
Review panel
Microbiology
Applicant
Visby Medical, Inc. 3010 N. First St., San Jose CA
Third party review
No

Clearances, product code SEA

Trailing 12 months

FDA records hold no clearances under product code SEA in the trailing twelve months.

FDA records show no clearances under product code SEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260