510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240045Unknown

Teal Wand

Teal Health, Inc., San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240045 is the FDA 510(k) clearance record for Teal Wand, a class II device, cleared for Teal Health, Inc. on under FDA product code SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay). FDA's definition for product code SEP reads: "A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for...". FDA records list one 510(k) clearance for Teal Health, Inc. As of , FDA records show no recalls naming DEN240045.

Clearance record

Decision date
Received
(255 days to decision)
Product code
SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Regulation
21 CFR 866.2920
Device class
Class II
Review panel
Microbiology
Applicant
Teal Health, Inc. 1012 Torney Ave., San Francisco CA
Third party review
No

Clearances, product code SEP

Trailing 12 months
1 clearance under product code SEP in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260